Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

NCT00495469 | Completed Phase 2 Results FDA Drug

• 1 other identifier: KG2110375
• Study Type: interventional
• Target: 250
• Locations: 16 countries
• Sites: 157

Brief Summary

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus HbA1c

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12

  The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.

  Baseline (Week 0) and at Week 12

Secondary Outcomes (18)

• Mean Change From Baseline in HbA1c at Weeks 4 and 8

  Baseline (Week 0) and at Week 4 nad 8

• Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)

  Baseline (Week 0) and at Week 12

• Mean Change From Baseline to Week 12 in Fructosamine (Corrected)

  Baseline (Week 0) and at Week 12

• Number of Participants Who Were HbA1c Responders at Week 12

  Week 12

• Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12

  Week 12

Study Arms (2)

GSK189075

EXPERIMENTAL

Participants will receive GSK189075 for 12 weeks

Drug: GSK189075

Placebo

PLACEBO COMPARATOR

Participants will receive GSK189075 matching Placebo for 12 weeks

Drug: Placebo

Interventions

GSK189075 DRUG

GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet

GSK189075

Placebo DRUG

Available as Placebo matching tablet to GSK189075

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a documented diagnosis of T2DM and HbA1c ≥7.0% and ≤9.5% measured by the central laboratory at Visit 1.
• Note: Subjects with HbA1c \<7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0, prior to randomization.
• Note: The proportion of subjects who are randomized with an HbA1c \<7.5% will be limited to be no more than 20% (approximately 51 subjects)
• Subjects who are treatment-naïve, and have not taken insulin, or any oral or injectable anti-diabetic medication in the past 3 months and have not taken a glucose lowering agent for ≥4 weeks at any time in the past, or subjects who are newly diagnosed and treated with diet and exercise for a minimum of 6 weeks
• Subjects who are 18 to 70 years of age inclusive at the time of Screening.
• Females of childbearing and non-childbearing and potential are eligible to participate as follows:
• Women of childbearing potential must be willing to use one of the following contraception methods: intrauterine device, condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent for at least 30 days prior to the start of study medication, throughout the study and the follow-up visit. Note: use of oral contraceptives is not permitted.
• Women of non-child bearing potential are defined as follows: females regardless of age, with functioning ovaries who have a current documented tubal ligation, or who are surgically sterile (i.e. documented total hysterectomy or bilateral oophorectomy), or females who are post-menopausal.
• All females must have a negative urine pregnancy test on the day of, and prior to randomization.
• Informed Consent: a signed and dated written consent must be obtained from the subject before any procedures are performed.

You may not qualify if:

• Metabolic Disease
• Diagnosis of Type 1 diabetes mellitus
• History of ketoacidosis which has required hospitalization
• Thyroid disorder
• TSH \<0.4 MIU/L (\<0.4 MCIU/mL) or \>5.5 mIU/L (\>5.5 MCIU/mL) at Screening
• BMI of \<22 kg/m2 or \>43 kg/m2
• Significant weight gain or loss (as defined as \>5% of total body weight) in the 3 months prior to Screening
• Diabetic Medication
• Has taken insulin, or any oral or injectable anti-diabetic medication within 3 months of screening
• Has taken insulin or any oral or injectable anti-diabetic medication ≥4 weeks at any time in the past
• Cardiovascular Disease
• Recent history or presence of clinically significant acute cardiovascular disease including:
• Documented myocardial infarction in the 6 months prior to Screening.
• Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either planned and/or occurred in the 6 months prior to Screening.
• Unstable angina in the 6 months prior to Screening.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (157)

GSK Investigational Site

Mesa, Arizona, 85206, United States

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GSK Investigational Site

Artesia, California, 90701, United States

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GSK Investigational Site

Buena Park, California, 90620, United States

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GSK Investigational Site

Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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GSK Investigational Site

La Jolla, California, 92037, United States

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GSK Investigational Site

Norwalk, California, 90650, United States

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Petaluma, California, 94954, United States

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Sacramento, California, 95823, United States

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San Mateo, California, 94401, United States

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Santa Ana, California, 92701, United States

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Tarzana, California, 91356, United States

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Torrance, California, 90505, United States

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Deland/Florida, Florida, 32720, United States

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Hollywood, Florida, 33023, United States

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Jacksonville/Florida, Florida, 32223, United States

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Miami, Florida, 33156, United States

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Miami, Florida, 33169, United States

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Ocoee/Florida, Florida, 34761, United States

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Saint Cloud, Florida, 34769, United States

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Atlanta, Georgia, 30322, United States

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Atlanta, Georgia, 30342, United States

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Bloomingdale, Illinois, 60108, United States

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Chicago, Illinois, 60616, United States

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Oak Brook, Illinois, 60523, United States

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South Bend, Indiana, 46614, United States

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Lafayette, Louisiana, 70503, United States

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Lake Charles, Louisiana, 70601, United States

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Oxon Hill, Maryland, 20745, United States

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Boston, Massachusetts, 02118, United States

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Gulfport, Mississippi, 39501, United States

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Jackson, Mississippi, 39202, United States

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Kosciusko, Mississippi, 39090, United States

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Rolling Fork, Mississippi, 39159, United States

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Chesterfield, Missouri, 63017, United States

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Saint Louis/Missouri, Missouri, 63118, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89016, United States

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Las Vegas, Nevada, 89106, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89128, United States

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Clifton, New Jersey, 7011, United States

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Albuquerque, New Mexico, 87102, United States

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Commack, New York, 11725, United States

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Ithaca, New York, 14850, United States

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New York, New York, 10032, United States

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Asheboro/North Carolina, North Carolina, 27203, United States

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Canal Fulton, Ohio, 44614, United States

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Bensalem/Pennsylvania, Pennsylvania, 19020, United States

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West Chester, Pennsylvania, 19382, United States

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Manning, South Carolina, 29102, United States

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Simpsonville, South Carolina, 29681, United States

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Athens/Tennessee, Tennessee, 37303, United States

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Corpus Christi, Texas, 78404, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75235, United States

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Harlingen/Texas, Texas, 78550, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77081, United States

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Midland, Texas, 79705, United States

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San Anonio, Texas, 78221, United States

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San Antonio, Texas, 78229, United States

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Burke, Virginia, 22015, United States

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Bellevue, Washington, 98004, United States

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Langley, British Columbia, V3A 4H9, Canada

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Bathurst, New Brunswick, E2A 4X7, Canada

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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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Brampton, Ontario, L6T 3T1, Canada

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Mississauga, Ontario, L5A 3V4, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Ottawa, Ontario, K1K 4K4, Canada

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Thornhill, Ontario, L4J 8L7, Canada

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Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M4R 2G4, Canada

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

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Québec, G1V 4G5, Canada

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Brno, 624 00, Czechia

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Brno, 636 00, Czechia

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Prague, 100 00, Czechia

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Prague, 158 00, Czechia

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Pärnu, 80018, Estonia

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Tallinn, 13415, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Allmendingen, Baden-Wurttemberg, 89604, Germany

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Wangen, Baden-Wurttemberg, 88239, Germany

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Großheirath, Bavaria, 96269, Germany

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Hohenau, Bavaria, 94545, Germany

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Künzing, Bavaria, 94550, Germany

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Munich, Bavaria, 80339, Germany

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Munich, Bavaria, 80469, Germany

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Parsberg, Bavaria, 92331, Germany

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Ruhmannsfelden, Bavaria, 94239, Germany

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Sulzbach-Rosenberg, Bavaria, 92237, Germany

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Falkensee, Brandenburg, 14612, Germany

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Brinkum/Stuhr, Lower Saxony, 28816, Germany

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Einbeck, Lower Saxony, 37574, Germany

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Hanover, Lower Saxony, 30159, Germany

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Lüneburg, Lower Saxony, 21339, Germany

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Tostedt, Lower Saxony, 21255, Germany

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Haßloch, Rhineland-Palatinate, 67454, Germany

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Ingelheim, Rhineland-Palatinate, 55218, Germany

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Dresden, Saxony, 01129, Germany

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Freital, Saxony, 01705, Germany

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Schmiedeberg, Saxony, 01762, Germany

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Wolmirstedt, Saxony-Anhalt, 39326, Germany

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Lübeck, Schleswig-Holstein, 23568, Germany

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Berlin, 10115, Germany

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Berlin, 10249, Germany

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Berlin, 12524, Germany

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Berlin, 13347, Germany

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Athens, 115 27, Greece

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Athens, 11528, Greece

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Thessaloniki, 564 29, Greece

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Thessaloniki, 56429, Greece

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Bangalore, 560034, India

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Bangalore, 560043, India

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Chennai, 600010, India

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Mumbai, 400007, India

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Pune, 411004, India

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Kaunas, LT-48259, Lithuania

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Kaunas, LT-50009, Lithuania

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Kaunas, LT-51270, Lithuania

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Vilnius, LT-08661, Lithuania

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Guadalajara, Jalisco, 44150, Mexico

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Cuernavaca, Morelos, 62250, Mexico

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Mérida, Yucatán, 97129, Mexico

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Durango, 34070, Mexico

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Rotorua, 3201, New Zealand

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Bydgoszcz, 85-021, Poland

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Porąbka, 43-353, Poland

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Siemianowice Śląskie, 41-103, Poland

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Wroclaw, 50-349, Poland

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Aibonito/Puerto Rico, Puerto Rico, 00705, Puerto Rico

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Trujillo Alto/Puerto Rico, Puerto Rico, 00976, Puerto Rico

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Caguas, 00725, Puerto Rico

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Carolina, 00983, Puerto Rico

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Ponce, 00717, Puerto Rico

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Rio Piedras, 00921, Puerto Rico

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Arad, 310011, Romania

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Brasov, 500365, Romania

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Sfântu Gheorghe, 520064, Romania

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Timișoara, 300736, Romania

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Moscow, 129110, Russia

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Saint Petersburg, 191025, Russia

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Saint-Peterburgh, 197022, Russia

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Tomsk, 634 050, Russia

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Tyumen, 625023, Russia

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Lenasia South, Gauteng, 01827, South Africa

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Bellville, 7530, South Africa

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Gauteng, 1459, South Africa

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Parow, 7505, South Africa

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GSK Investigational Site

Roodepoort, 1709, South Africa

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GSK Investigational Site

Dnipropetrovsk, 49027, Ukraine

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GSK Investigational Site

Kyiv, 02091, Ukraine

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GSK Investigational Site

Vinnitsa, 21010, Ukraine

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Related Publications (1)

• Sykes AP, Kemp GL, Dobbins R, O'Connor-Semmes R, Almond SR, Wilkison WO, Walker S, Kler L. Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):98-101. doi: 10.1111/dom.12393. Epub 2014 Nov 3.

  PMID: 25238025 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: August 17, 2007
• Primary Completion: June 5, 2008
• Study Completion: June 5, 2008
• Last Updated: October 30, 2017
• Results First Posted: October 30, 2017

Record last verified: 2017-09

Locations

LI (4); CA (12); PL (4); CZ (4); DE (27); IN (5); ES (4); ZA (5); UA (3); PR (6); RO (4); GR (4); NZ (1); US (65); ME (4); RU (5)