A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755287
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: insulin glargine Drug: metformin Drug: taspoglutide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1072 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy
Study Start Date : November 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: insulin glargine
insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
Drug: insulin glargine
starting dose 10 IU daily

Drug: metformin
As prescribed

Experimental: taspoglutide 10 mg
taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
Drug: metformin
As prescribed

Drug: taspoglutide
10 mg once weekly

Experimental: taspoglutide 10 mg/20 mg
taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
Drug: metformin
As prescribed

Drug: taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)

Primary Outcome Measures :
  1. Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile. [ Time Frame: 24 weeks ]
  2. Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. [ Time Frame: 24 weeks ]
  3. Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies [ Time Frame: Throughout study ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
  • C-peptide (fasting) >=1.0ng/mL;
  • HbA1c >=7.0% and <=10.0% at screening;
  • BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
  • stable weight +-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

  • history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
  • evidence of clinically significant diabetic complications;
  • symptomatic poorly controlled diabetes;
  • clinically symptomatic gastrointestinal disease;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
  • known hemoglobinopathy or chronic anemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755287

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Searcy, Arkansas, United States, 72143
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Concord, California, United States, 94520
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Sheffield, United Kingdom, S18 1RU
Trowbridge, United Kingdom, BA14 8QA
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00755287     History of Changes
Other Study ID Numbers: BC20965
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists