A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

NCT00823992 | Completed Phase 3

• 2 other identifiers: BC220922008-005809-20
• Study Type: interventional
• Target: 305
• Locations: 10 countries
• Sites: 71

Brief Summary

This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in HbA1c

  24 weeks

Secondary Outcomes (3)

• Change from baseline in body weight;% of patients achieving >=5% weight loss

  24 weeks

• % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function

  24 weeks

• Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n

  At planned clinic visits, for 12 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

taspoglutide

EXPERIMENTAL

Drug: taspoglutide

Interventions

placebo DRUG

sc once weekly

placebo

taspoglutide DRUG

10mg sc once weekly for 4 weeks, then 20mg sc once weekly

taspoglutide

Eligibility Criteria

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

You may qualify if:

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks;
• HbA1c \>=6.5% and \<=9.5% at screening;
• BMI \>=30 and \<=50 kg/m2 at screening;
• stable weight +/-5% for at least 12 weeks prior to screening.

You may not qualify if:

• history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
• evidence of clinically significant diabetic complications;
• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (71)

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Bermuda Dunes, California, 92203, United States

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La Jolla, California, 92037, United States

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Los Angeles, California, 90057, United States

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Mission Viejo, California, 92691, United States

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Brooksville, Florida, 34601, United States

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Miami, Florida, 33133, United States

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St. Petersburg, Florida, 33709, United States

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Atlanta, Georgia, 30342, United States

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Chicago, Illinois, 60607, United States

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Avon, Indiana, 46123, United States

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New Orleans, Louisiana, 70121, United States

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Bangor, Maine, 04401, United States

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Royal Oak, Michigan, 48073, United States

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Picayune, Mississippi, 39466, United States

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Clifton, New Jersey, 07012, United States

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Toms River, New Jersey, 08753, United States

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Albuquerque, New Mexico, 87131, United States

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New York, New York, 10025, United States

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Springfield Gardens, New York, 11413, United States

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Charlotte, North Carolina, 28277, United States

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Shelby, North Carolina, 28150, United States

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Norman, Oklahoma, 73069, United States

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Medford, Oregon, 97504, United States

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Clinton, South Carolina, 29325, United States

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Kingsport, Tennessee, 37660, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77074, United States

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Midland, Texas, 79707, United States

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San Antonio, Texas, 78237, United States

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Vancouver, British Columbia, V5Z 1L8, Canada

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Sherbrooke, Nova Scotia, J1G 2E8, Canada

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Etobicoke, Ontario, M9R 4E1, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Aschaffenburg, 63739, Germany

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Berlin, 10115, Germany

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Bochum, 44791, Germany

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Dortmund, 44137, Germany

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Dresden, 01307, Germany

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Falkensee, 14612, Germany

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Mainz, 55116, Germany

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Münster, 48145, Germany

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Neuwied, 56564, Germany

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Ancona, 60131, Italy

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Ravenna, 48100, Italy

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Roma, 00161, Italy

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Siena, 53100, Italy

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Bitola, 7000, North Macedonia

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Gniewkowo, 88-140, Poland

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Kamieniec Ząbkowicki, 57-230, Poland

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Lublin, 20-044, Poland

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Carolina, 00983, Puerto Rico

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Rio Piedras, 00921, Puerto Rico

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Río Grande, 00745, Puerto Rico

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Kemerovo, 650002, Russia

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Moscow, 105229, Russia

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Moscow, 115280, Russia

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Moscow, 117036, Russia

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Ryazan, 390026, Russia

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Saratov, 410002, Russia

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Smolensk, 214019, Russia

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Tyumen, 625023, Russia

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Barcelona, 08036, Spain

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Lleida, 25198, Spain

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Oviedo, 33006, Spain

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Bath, BA2 4BY, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Glasgow, G45 9AW, United Kingdom

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Midsomer Norton, BA3 2UH, United Kingdom

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Rotherham, S65 1DA, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

taspoglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

DE (9); US (29); PR (3); ES (3); IT (4); NO (1); GB (5); PL (3); CA (6); RU (8)