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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01051011
Recruitment Status : Terminated (high discontinuation rates mainly due to GI tolerability and implementation of risk mitigation plan to address hypersensitivity reactions)
First Posted : January 18, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: insulin glargine Drug: metformin Drug: taspoglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: metformin
as prescribed

Drug: taspoglutide
10mg sc weekly, 24 (-52) weeks
Experimental: 2 Drug: metformin
as prescribed

Drug: taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
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


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic control assessed by HbA1c [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c [ Time Frame: week 24 ]
  2. Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio) [ Time Frame: week 24 ]
  3. Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters [ Time Frame: throughout study, laboratory assessments weeks 12, 24, 32 and 52 ]
  4. Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values [ Time Frame: week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051011


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01051011    
Other Study ID Numbers: ZC22565
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Insulin Glargine
 Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists