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.
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ClinicalTrials.gov Identifier: NCT00755287 |
Recruitment Status
:
Completed
First Posted
: September 18, 2008
Last Update Posted
: July 29, 2016
|
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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 |

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)
|
- Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]
- 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 ]
- Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. [ Time Frame: 24 weeks ]
- 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, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00755287

Study Director: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00755287 History of Changes |
Other Study ID Numbers: |
BC20965 2008-001855-23 |
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 Metformin |
Insulin Glargine Glucagon-Like Peptide 1 Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |