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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00755287
First received: September 17, 2008
Last updated: July 27, 2016
Last verified: July 2016
September 17, 2008
July 27, 2016
November 2008
December 2010   (Final data collection date for primary outcome measure)
Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT00755287 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • 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)
  • 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
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.
 
Completed
1072
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
China
 
NCT00755287
BC20965
2008-001855-23
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP