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. - Full Text View

Purpose

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	Intervention	Phase
Diabetes Mellitus Type 2	Drug: insulin glargine Drug: metformin Drug: taspoglutide	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Insulin Insulin human Insulin glargine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

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 ]


Enrollment:	1072
Study Start Date:	November 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00755287

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Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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
Study First Received:	September 17, 2008
Last Updated:	July 27, 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

ClinicalTrials.gov processed this record on July 21, 2017