A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

July 26, 2016 updated by: Hoffmann-La Roche

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks 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 1 year, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
      • St. Leonards, Australia, 2065
  • Guatemala
      • Guatemala, Guatemala, 01010
      • Guatemala, Guatemala, 01014
  • Israel
      • Haifa, Israel, 31096
      • Haifa, Israel, 34162
      • Holon, Israel, 58100
      • Jerusalem, Israel, 91200
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49100
      • Tel Aviv, Israel, 64239
  • Mexico
      • Acapulco, Mexico, 39670
      • Aguascalientes, Mexico, 20230
      • Chihuahua, Mexico, 31238
      • Hermosillo, Mexico, 83200
      • Mexico City, Mexico, 11650
      • Morelia, Mexico, 58000
  • Peru
      • Lima, Peru, Lima 33
      • San Isidro, Peru, 27
  • Romania
      • Bucuresti, Romania, 020359
      • Buzau, Romania, 120203
      • Cluj-napoca, Romania, 400006
      • Ploiesti, Romania, 100163
      • Ploiesti, Romania, 100342
      • Tg. Mures, Romania, 540142
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454136
      • Jaloslave, Russian Federation
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 109263
      • Moscow, Russian Federation, 119048
      • S. Petersburg, Russian Federation, 195067
      • S.petersburg, Russian Federation, 194017
      • St. Petersburg, Russian Federation, 191124
      • Yaroslavl, Russian Federation, 150062
  • Slovakia
      • Dolny Kubin, Slovakia, 02601
      • Levice, Slovakia, 034 01
      • Presov, Slovakia, 080 01
      • Trencin, Slovakia, 911 01
      • Zilina, Slovakia, 010 01
  • Taiwan
      • Changhua, Taiwan, 500
      • Tainan, Taiwan, 710
      • Taipei, Taiwan, 100
      • Tapei County, Taiwan, 231
  • Ukraine
      • Chernovtsy, Ukraine, 58002
      • Kiev, Ukraine, 01601
      • Kiev, Ukraine, 04050
      • Lviv, Ukraine, 79010
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
    • California
      • Los Angeles, California, United States, 90057
      • Santa Ana, California, United States, 92701
    • Indiana
      • Avon, Indiana, United States, 46123
    • Nevada
      • Pahrump, Nevada, United States, 89048
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
    • South Carolina
      • Greer, South Carolina, United States, 29651
      • Mount Pleasant, South Carolina, United States, 29464
    • Texas
      • San Antonio, Texas, United States, 78237
    • Virginia
      • Richmond, Virginia, United States, 23294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
  • tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
  • C-peptide (fasting) >=1.0ng/mL
  • HbA1c >=6.5% 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;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
  • known hemoglobinopathy or chronic anemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
sc, once weekly
Experimental: taspoglutide 10mg sc
Drug: taspoglutide
10mg sc, once weekly
Drug: taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Experimental: taspoglutide 10mg/20mg sc
Drug: taspoglutide
10mg sc, once weekly
Drug: taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in HbA1c
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Time Frame: Throughout study
Throughout study
Change from baseline in fasting plasma glucose; change from baseline in body weight.
Time Frame: 24 weeks
24 weeks
Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC20750
  • 2008-001765-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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