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A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

This study has been terminated.
(high discontinuation rates mainly due to GI tolerability and implementation of risk mitigation plan to address hypersensitivity reactions)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051011
First received: January 15, 2010
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: taspoglutide
Drug: insulin glargine
Drug: metformin
 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: A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Glycemic control assessed by HbA1c [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters [ Time Frame: throughout study, laboratory assessments weeks 12, 24, 32 and 52 ] [ Designated as safety issue: No ]
  • Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Enrollment: 353
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg sc weekly, 24 (-52) weeks
Drug: metformin
as prescribed
Experimental: 2 Drug: taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Drug: metformin
as prescribed
Active Comparator: 3 Drug: insulin glargine
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
Drug: metformin
as prescribed

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-75 years of age
  • type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening
  • HbA1c 7-10% at screening
  • body weight stable (+/-5%) for >/= 12 weeks prior to screening
  • fasting C-peptide >/=1ng/ml
  • treatment-naïve for insulin

Exclusion Criteria:

  • diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
  • acute metabolic diabetic complications or evidence of clinically significant diabetic complications
  • clinically symptomatic gastrointestinal disease
  • history of chronic pancreatitis or acute idiopathic pancreatitis
  • >3 episodes of severe hypoglycemia within 6 months prior to screening
  • miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
  • any treatment with exenatide, exendin analogues, GLP-1 or its analogues
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051011

  Show 56 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01051011     History of Changes
Other Study ID Numbers: ZC22565
Study First Received: January 15, 2010
Last Updated: November 21, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013