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.

July 27, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1072

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

    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
      • Wollongong, New South Wales, Australia, 2500
    • Queensland
      • Freemantle, Queensland, Australia, 6959
      • Graz, Austria, 8036
      • Salzburg, Austria, 5020
      • Wien, Austria, 1030
      • Wien, Austria, 1130
      • Wien, Austria, 1080
      • Arlon, Belgium, 6700
      • Bonheiden, Belgium, 2820
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
    • PE
      • Recife, PE, Brazil, 52051-380
    • PR
      • Campina Grande do Sul, PR, Brazil, 83430-000
      • Curitiba, PR, Brazil, 80030-110
    • RS
      • Porto Alegre, RS, Brazil, 90035-170
    • SP
      • Sao Paulo, SP, Brazil, 04022-001
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
      • London, Ontario, Canada, N6A 5R8
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Sherbrooke, Quebec, Canada, J1G 5K2
      • Brno, Czech Republic, 625 00
      • Havirov, Czech Republic, 76301
      • Plzen, Czech Republic, 301 00
      • Praha, Czech Republic, 180 00
      • Trutnov, Czech Republic, 541 01
      • Helsinki, Finland, 00150
      • Jyvaeskylae, Finland, 40100
      • Tampere, Finland, 33100
      • Avignon, France, 84902
      • Besancon, France, 25030
      • Bois Guillaume, France, 76233
      • Brest, France, 29609
      • Corbeil Essonnes, France, 91106
      • La Rochelle, France, 17019
      • Marseille, France, 13385
      • Marseille, France, 13015
      • Montpellier, France, 34295
      • Nimes, France, 30029
      • Paris, France, 75908
      • Paris, France, 75651
      • Paris, France, 75877
      • Strasbourg, France, 67091
      • Venissieux, France, 69200
      • Bad Lauterberg, Germany, 37431
      • Berlin, Germany, 10115
      • Bochum, Germany, 44869
      • Bosenheim, Germany, 55545
      • Dortmund, Germany, 44137
      • Falkensee, Germany, 14612
      • Freiburg, Germany, 79106
      • Mainz, Germany, 55116
      • Offenbach a.M., Germany, 63065
      • Reichenbach, Germany, 08468
      • Würzburg, Germany, 97072
      • Athens, Greece, 10552
      • Larissa, Greece, 41110
      • Thessaloniki, Greece, 56429
      • Guatemala, Guatemala, 01010
      • Hong Kong, Hong Kong
      • Balatonfuered, Hungary, 8230
      • Budapest, Hungary, 1045
      • Szekszard, Hungary, 7100
    • Campania
      • Napoli, Campania, Italy, 80100
    • Lazio
      • Roma, Lazio, Italy, 00157
    • Lombardia
      • Codogno, Lombardia, Italy, 26845
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20142
    • Piemonte
      • Torino, Piemonte, Italy, 10126
      • Daegu, Korea, Republic of, 700-721
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of, 137-040
      • Aguascalientes, Mexico, 20127
      • Cuernavaca, Mexico, 62250
      • Monterrey, Mexico, 64410
      • Tampico, Mexico, 89000
      • Auckland, New Zealand
      • Auckland, New Zealand, 1640
      • Arequipa, Peru, Cercado
      • Lima, Peru, Lima 33
      • Lima, Peru, Lima 1
      • Trujillo, Peru, 13011
      • Grodzisk Mazowiecki, Poland, 05-825
      • Kamieniec Zabkowicki, Poland, 57-230
      • Lodz, Poland, 93-338
      • Rzeszow, Poland, 35-073
      • Sobótka, Poland, 55-050
      • Szczecin, Poland, 71-455
      • Wroclaw, Poland, 51-124
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1349-019
      • Lisboa, Portugal, 1250-203
      • Guyanabo, San Juan, Puerto Rico, 00920
      • Levittown, Puerto Rico, 00950
      • Orocovis, Puerto Rico, 00720
      • Ponce, Puerto Rico, 00717-322
      • San Juan, Puerto Rico, 00926-2832
      • Trujillo Alto, Puerto Rico, 00976
      • Barnaul, Russian Federation, 656024
      • Chelyabinsk, Russian Federation, 454136
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 125299
      • Moscow, Russian Federation, 117049
      • Nizhny Novgorod, Russian Federation, 603126
      • Novosibirsk, Russian Federation, 630047
      • Omsk, Russian Federation, 644021
      • Saint-Petersburg, Russian Federation, 197022
      • St Petersburg, Russian Federation, 195213
      • St-Petersburg, Russian Federation, 194291
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 193012
      • Tomsk, Russian Federation, 643050
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
      • Nis, Serbia, 18000
      • Novi Sad, Serbia, 21000
      • Almeria, Spain, 04001
      • Barcelona, Spain, 08025
      • Granada, Spain, 18012
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41010
      • Valencia, Spain, 46014
      • Valencia, Spain, 46010
      • Valladolid, Spain, 47005
    • Madrid
      • Pozuelo de alarcon, Madrid, Spain, 28223
    • Valencia
      • Alzira, Valencia, Spain, 46600
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • Atherstone, United Kingdom, CV9 1EU
      • Chesterfield, United Kingdom, S40 4TF
      • Dumfries, United Kingdom, DG1 4AP
      • Liverpool, United Kingdom, L9 7AL
      • Sheffield, United Kingdom, S18 1RU
      • Trowbridge, United Kingdom, BA14 8QA
    • Arizona
      • Phoenix, Arizona, United States, 85032
    • Arkansas
      • Searcy, Arkansas, United States, 72143
    • California
      • Concord, California, United States, 94520
      • Huntington Beach, California, United States, 92648
      • Los Angeles, California, United States, 90025
      • Los Angeles, California, United States, 90015
      • Los Gatos, California, United States, 95032
      • Roseville, California, United States, 95661
      • San Diego, California, United States, 92109
      • Santa Ana, California, United States, 92705
      • Westlake Village, California, United States, 91361
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Green Cove Springs, Florida, United States, 32043
      • Hialeah, Florida, United States, 33013
      • Jacksonville, Florida, United States, 32204
      • Jacksonville, Florida, United States, 32216
      • Ormond Beach, Florida, United States, 32174
      • Oviedo, Florida, United States, 32765
      • Palm Harbor, Florida, United States, 34684
      • Trinity, Florida, United States, 34655
      • Zephyrhills, Florida, United States, 33542
    • Georgia
      • Atlanta, Georgia, United States, 30338
    • Illinois
      • Quincy, Illinois, United States, 62301
      • Springfield, Illinois, United States, 62704-1433
    • Indiana
      • Avon, Indiana, United States, 46123
      • Indianapolis, Indiana, United States, 46260
    • Kansas
      • Arkansas City, Kansas, United States, 67005
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
    • Louisiana
      • Metairie, Louisiana, United States, 70006
      • Sunset, Louisiana, United States, 70584
    • Maine
      • Portland, Maine, United States, 04101
    • Maryland
      • North East, Maryland, United States, 21901
    • Massachusetts
      • Worchester, Massachusetts, United States, 01605
    • Michigan
      • St. Claire Shores, Michigan, United States, 48081
    • Mississippi
      • Jackson, Mississippi, United States, 39216
      • Picayune, Mississippi, United States, 39466
    • Missouri
      • Springfield, Missouri, United States, 65807
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
      • Omaha, Nebraska, United States, 68105
      • Omaha, Nebraska, United States, 68131
    • Nevada
      • Henderson, Nevada, United States, 89014
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
      • Cherry Hill, New Jersey, United States, 08002
      • Moorestown, New Jersey, United States, 08057
      • Toms River, New Jersey, United States, 08755
      • Toms River, New Jersey, United States, 08753
    • New York
      • Albany, New York, United States, 12206-1098
      • Flushing, New York, United States, 11365
      • Mineola, New York, United States, 11501
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Harrisburg, North Carolina, United States, 28075
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Centerville, Ohio, United States, 45459
      • Cincinnati, Ohio, United States, 45242
      • Genoa, Ohio, United States, 43430-1143
      • Toledo, Ohio, United States, 43606
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
      • Bensalem, Pennsylvania, United States, 19020
      • Feasterville, Pennsylvania, United States, 19053
      • Harrisburg, Pennsylvania, United States, 17112
      • Jefferson Hills, Pennsylvania, United States, 15025
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19146
      • Scranton, Pennsylvania, United States, 18510
      • Tipton, Pennsylvania, United States, 16684
    • South Carolina
      • Orangeburg, South Carolina, United States, 29115
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
    • Texas
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
    • Virginia
      • Richmond, Virginia, United States, 23249
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53189

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: insulin glargine
insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
starting dose 10 IU daily
As prescribed
Experimental: taspoglutide 10 mg
taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
As prescribed
10 mg once weekly
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
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
As prescribed
10 mg once weekly
20 mg once weekly (after 4 weeks of taspoglutide 10 mg 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
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
24 weeks
Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.
Time Frame: 24 weeks
24 weeks
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

November 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

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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