A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both. - Full Text View

Purpose

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: exenatide Drug: taspoglutide	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Metformin Exenatide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Proportion of patients reaching target HbA1c <=7.0%, <=6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Beta cell function (proinsulin/insulin ratio) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]


Enrollment:	1189
Study Start Date:	July 2008
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: exenatide	Drug: exenatide 5mg twice daily for 4 weeks followed by 10mg twice daily
Experimental: taspoglutide 10mg	Drug: taspoglutide 10mg once weekly
Experimental: taspoglutide 10mg/20mg	Drug: taspoglutide 10mg once weekly for 4 weeks followed by 20mg once weekly

Eligibility


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

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
HbA1c >=7.0% and <=10% at screening;
BMI >=25kg/m2 (>23kg/m2 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, diabetes resulting from pancreatic injury or secondary forms of diabetes;
history of acute metabolic diabetic complications within the previous 6 months;
evidence of clinically significant diabetic complications;
known proliferative diabetic retinopathy;
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
known hemoglobinopathy or chronic anemia;
clinically significant gastrointestinal disease.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717457

Show 216 Study Locations

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):

Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00717457 History of Changes
Other Study ID Numbers:	BC21625 2008-001856-36
Study First Received:	July 16, 2008
Last Updated:	September 1, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide 2,4-thiazolidinedione	Metformin Glucagon-Like Peptide 1 Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016