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A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00754988
First received: September 17, 2008
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: Metformin
Drug: Placebo (matching sitagliptin)
Drug: Placebo (matching taspoglutide)
Drug: Sitagliptin
Drug: Taspoglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean changes in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; change from baseline in lipid profile; beta cell function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 666
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Drug: Metformin
As prescribed
Drug: Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Drug: Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Active Comparator: Sitagliptin
Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Drug: Metformin
As prescribed
Drug: Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Drug: Sitagliptin
Once daily oral administration of 100 mg of sitagliptin.
Experimental: Taspoglutide 10 mg
Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Drug: Metformin
As prescribed
Drug: Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Drug: Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Experimental: Taspoglutide up-titrated to 20 mg
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Drug: Metformin
As prescribed
Drug: Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
Drug: Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.

  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 (>=1500mg/day) for at least 12 weeks;
  • 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;
  • 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.
  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: NCT00754988

  Show 148 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00754988     History of Changes
Other Study ID Numbers: BC21713  2008-001854-42 
Study First Received: September 17, 2008
Last Updated: November 3, 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
Metformin
Sitagliptin Phosphate
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016