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.

Tracking Information
First Submitted Date ICMJE	September 17, 2008
First Posted Date ICMJE	September 18, 2008
Last Update Posted Date	July 29, 2016
Study Start Date ICMJE	November 2008
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 17, 2008)	Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00755287 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 17, 2008)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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.
Official Title ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus Type 2
Intervention ICMJE	Drug: insulin glargine starting dose 10 IU daily; Drug: metformin As prescribed; Drug: taspoglutide 10 mg once weekly; Drug: taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
Study Arms	Active Comparator: insulin glargine insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment Interventions: Drug: insulin glargine Drug: metformin; Experimental: taspoglutide 10 mg taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment Interventions: Drug: metformin Drug: taspoglutide; 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 Interventions: Drug: metformin Drug: taspoglutide
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 16, 2010)	1072
Original Estimated Enrollment ICMJE; (submitted: September 17, 2008)	990
Actual Study Completion Date	December 2010
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Portugal, Puerto Rico, Russian Federation, Serbia, Spain, Thailand, United Kingdom, United States
Removed Location Countries	China
Administrative Information
NCT Number ICMJE	NCT00755287
Other Study ID Numbers ICMJE	BC20965; 2008-001855-23
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hoffmann-La Roche
Study Sponsor ICMJE	Hoffmann-La Roche
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Clinical Trials Hoffmann-La Roche
PRS Account	Hoffmann-La Roche
Verification Date	July 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP