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.

Study Description

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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 Design

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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

Arms and Interventions

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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)

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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  Show 210 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.

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
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