A New Oral Treatment For Type II Diabetes Mellitus

NCT00111800 | Completed Phase 2 Results

• 1 other identifier: DPB100925
• Study Type: interventional
• Target: 375
• Locations: 10 countries
• Sites: 109

Brief Summary

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

NIDDM

Outcome Measures

Primary Outcomes (1)

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

  HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.

  Baseline (Week 0) and Week 12

Secondary Outcomes (26)

• Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24

  Baseline (Week 0) up to Week 24

• Change From Baseline in FPG at Week 12

  Baseline (Week 0) and Week 12

• Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24

  Baseline (Week 0) up to Week 24

• Number of Participants Who Were HbA1c Responders at Week 12

  Week 12

• Number of Participants of FPG Responders at Week 12

  Week 12

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.

Drug: Placebo

DEN 2.5 mg

EXPERIMENTAL

Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.

Drug: DEN 2.5 mg

DEN 7.5 mg

EXPERIMENTAL

Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.

Drug: DEN 7.5 mg

DEN 15 mg

EXPERIMENTAL

Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.

Drug: DEN 15 mg

DEN 30 mg

EXPERIMENTAL

Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.

Drug: DEN 30 mg

DEN 45 mg

EXPERIMENTAL

Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.

Drug: DEN 45 mg

Interventions

Placebo DRUG

Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Placebo

DEN 2.5 mg DRUG

DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Also known as: GW823093 2.5 mg

DEN 2.5 mg

DEN 7.5 mg DRUG

DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Also known as: GW823093 7.5 mg

DEN 7.5 mg

DEN 15 mg DRUG

DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Also known as: GW823093 15 mg

DEN 15 mg

DEN 30 mg DRUG

DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Also known as: GW823093 30 mg

DEN 30 mg

DEN 45 mg DRUG

DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Also known as: GW823093 45 mg

DEN 45 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must not be pregnant and must not be breastfeeding.
• Have Type II diabetes.
• Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

You may not qualify if:

• Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (109)

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Pasadena, California, 91105, United States

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GSK Investigational Site

Denver, Colorado, 80220, United States

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GSK Investigational Site

Hollywood, Florida, 33021, United States

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GSK Investigational Site

Miami, Florida, 33126, United States

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GSK Investigational Site

Atlanta, Georgia, 30308, United States

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GSK Investigational Site

Marietta, Georgia, 30066, United States

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GSK Investigational Site

Honolulu, Hawaii, 96813, United States

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GSK Investigational Site

Chicago, Illinois, 60607, United States

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GSK Investigational Site

Indianapolis, Indiana, 46202, United States

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GSK Investigational Site

Sunset, Louisiana, 70584, United States

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GSK Investigational Site

Oxon Hill, Maryland, 20745, United States

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GSK Investigational Site

Las Vegas, Nevada, 89106, United States

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GSK Investigational Site

Pahrump, Nevada, 89048, United States

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GSK Investigational Site

Albany, New York, 12208, United States

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GSK Investigational Site

Buffalo, New York, 14209, United States

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GSK Investigational Site

Johnson City, New York, 13790, United States

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GSK Investigational Site

Rochester, New York, 14642, United States

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GSK Investigational Site

Syracuse, New York, 13210, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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Raleigh, North Carolina, 27612, United States

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Cincinnati, Ohio, 45246, United States

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GSK Investigational Site

Kettering, Ohio, 45429, United States

Location

GSK Investigational Site

Jefferson Hills, Pennsylvania, 15025, United States

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GSK Investigational Site

Sewickley, Pennsylvania, 15143, United States

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GSK Investigational Site

Columbia, South Carolina, 29201, United States

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GSK Investigational Site

Kingsport, Tennessee, 37660, United States

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GSK Investigational Site

Arlington, Texas, 76017, United States

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GSK Investigational Site

Dallas, Texas, 75230, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

San Antonio, Texas, 78237, United States

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GSK Investigational Site

Salt Lake City, Utah, 84102, United States

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GSK Investigational Site

Burke, Virginia, 22015, United States

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GSK Investigational Site

Bellingham, Washington, 98226, United States

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GSK Investigational Site

Tacoma, Washington, 98403, United States

Location

GSK Investigational Site

Vancouver, Washington, 98664, United States

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

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GSK Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

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GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, A0G 1G0, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

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GSK Investigational Site

Toronto, Ontario, M4R 2G4, Canada

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Toronto, Ontario, M9W 4L6, Canada

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GSK Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

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Gatineau, Quebec, J8Y 6S8, Canada

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GSK Investigational Site

Mirabel, Quebec, J7J 2K8, Canada

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GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, G1W 4R4, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

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GSK Investigational Site

Brno, 656 51, Czechia

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GSK Investigational Site

Cheb, 350 02, Czechia

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GSK Investigational Site

České Budějovice, 370 87, Czechia

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GSK Investigational Site

Liberec, 46004, Czechia

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GSK Investigational Site

Prague, 128 21, Czechia

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GSK Investigational Site

Prague, 150 05, Czechia

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GSK Investigational Site

Prague, 158 00, Czechia

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GSK Investigational Site

Třebíč, 674 01, Czechia

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GSK Investigational Site

Helsinki, 00260, Finland

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GSK Investigational Site

Kuopio, 70210, Finland

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GSK Investigational Site

Oulu, 90100, Finland

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GSK Investigational Site

Bammental, Baden-Wurttemberg, 69245, Germany

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GSK Investigational Site

Deggingen, Baden-Wurttemberg, 73326, Germany

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GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

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GSK Investigational Site

Kippenheim, Baden-Wurttemberg, 77971, Germany

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GSK Investigational Site

Königsfeld im Schwarzwald, Baden-Wurttemberg, 78126, Germany

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GSK Investigational Site

Offenburg, Baden-Wurttemberg, 77654, Germany

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GSK Investigational Site

Sinsheim, Baden-Wurttemberg, 74889, Germany

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GSK Investigational Site

Stockach, Baden-Wurttemberg, 78333, Germany

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

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GSK Investigational Site

Haag, Bavaria, 83527, Germany

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GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany

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GSK Investigational Site

Bad Kreuznach, Hesse, 55545, Germany

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GSK Investigational Site

Hirschhorn, Hesse, 69434, Germany

Location

GSK Investigational Site

Kelkheim, Hesse, 65779, Germany

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GSK Investigational Site

Offenbach, Hesse, 63067, Germany

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GSK Investigational Site

Offenbach, Hesse, 63073, Germany

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GSK Investigational Site

Bad Lauterberg im Harz, Lower Saxony, 37431, Germany

Location

GSK Investigational Site

Lüneburg, Lower Saxony, 21335, Germany

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GSK Investigational Site

Tostedt, Lower Saxony, 21255, Germany

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GSK Investigational Site

Ingelheim, Rhineland-Palatinate, 55218, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

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GSK Investigational Site

Rhaunen, Rhineland-Palatinate, 55624, Germany

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GSK Investigational Site

Speyer, Rhineland-Palatinate, 67346, Germany

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GSK Investigational Site

Dresden, Saxony, 01129, Germany

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GSK Investigational Site

Dresden, Saxony, 01219, Germany

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GSK Investigational Site

Freital, Saxony, 01705, Germany

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GSK Investigational Site

Pirna, Saxony, 01796, Germany

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GSK Investigational Site

Schmiedeberg, Saxony, 01762, Germany

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GSK Investigational Site

Athens, 115 26, Greece

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GSK Investigational Site

Heraklion, Crete, 71409, Greece

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GSK Investigational Site

Lávrio, 19500, Greece

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GSK Investigational Site

Melíssia, 15127, Greece

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GSK Investigational Site

Thessaloniki, 546 42, Greece

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GSK Investigational Site

Thessaloniki, 551 32, Greece

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GSK Investigational Site

Thessaloniki, 564 29, Greece

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GSK Investigational Site

Thessaloniki, 564 34, Greece

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GSK Investigational Site

Jelgava, LV 3001, Latvia

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GSK Investigational Site

Ogre, LV 5001, Latvia

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GSK Investigational Site

Riga, LV 1002, Latvia

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GSK Investigational Site

Riga, LV1002, Latvia

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GSK Investigational Site

Riga, LV1079, Latvia

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GSK Investigational Site

Talsi, LV 3201, Latvia

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GSK Investigational Site

Valmiera, LV 4201, Latvia

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GSK Investigational Site

Ponce, 00716, Puerto Rico

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GSK Investigational Site

Brasov, 500366, Romania

Location

GSK Investigational Site

Bucharest, 020045, Romania

Location

GSK Investigational Site

Bucharest, 020475, Romania

Location

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

Location

GSK Investigational Site

Malmo, SE-205 02, Sweden

Location

GSK Investigational Site

Stockholm, SE-182 88, Sweden

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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: May 25, 2005
• First Posted: May 26, 2005
• Study Start: April 28, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 21, 2006
• Last Updated: March 21, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

FI (3); CZ (8); DE (28); SE (3); US (36); CA (12); LA (7); GR (8); PR (1); RO (3)