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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00755287
First received: September 17, 2008
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This 3-arm study will assess the efficacy, safety and tolerability of taspogluti de compared to insulin glargine in patients with insulin-naive type 2 diabetes m ellitus inadequately controlled with metformin and sulphonylurea combination the rapy. 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 th e target sample size if 500+ individuals.


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 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline 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%); incidence of hypoglycemia; change from baseline in lipid profile. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. [ 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: 1072
Study Start Date: November 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10 mg once weekly
Drug: metformin
As prescribed
Experimental: 2 Drug: taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
Drug: metformin
As prescribed
Active Comparator: 3 Drug: insulin glargine
starting dose 10 IU daily
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 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00755287

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Locations
United States, Arizona
Phoenix, Arizona, United States, 85032
United States, Arkansas
Searcy, Arkansas, United States, 72143
United States, 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
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, 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
United States, Georgia
Atlanta, Georgia, United States, 30338
United States, Illinois
Quincy, Illinois, United States, 62301
Springfield, Illinois, United States, 62704-1433
United States, Indiana
Avon, Indiana, United States, 46123
Indianapolis, Indiana, United States, 46260
United States, Kansas
Arkansas City, Kansas, United States, 67005
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Metairie, Louisiana, United States, 70006
Sunset, Louisiana, United States, 70584
United States, Maine
Portland, Maine, United States, 04101
United States, Maryland
North East, Maryland, United States, 21901
United States, Massachusetts
Worchester, Massachusetts, United States, 01605
United States, Michigan
St. Claire Shores, Michigan, United States, 48081
United States, Mississippi
Jackson, Mississippi, United States, 39216
Picayune, Mississippi, United States, 39466
United States, Missouri
Springfield, Missouri, United States, 65807
United States, Nebraska
Grand Island, Nebraska, United States, 68803
Omaha, Nebraska, United States, 68131
Omaha, Nebraska, United States, 68105
United States, Nevada
Henderson, Nevada, United States, 89014
United States, 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, 08753
Toms River, New Jersey, United States, 08755
United States, New York
Albany, New York, United States, 12206-1098
Flushing, New York, United States, 11365
Mineola, New York, United States, 11501
United States, North Carolina
Asheville, North Carolina, United States, 28803
Harrisburg, North Carolina, United States, 28075
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Centerville, Ohio, United States, 45459
Cincinnati, Ohio, United States, 45242
Genoa, Ohio, United States, 43430-1143
Toledo, Ohio, United States, 43606
United States, 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
United States, South Carolina
Orangeburg, South Carolina, United States, 29115
United States, Tennessee
Johnson City, Tennessee, United States, 37604
United States, Texas
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75390
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77030
Houston, Texas, United States, 77024
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Wisconsin
Waukesha, Wisconsin, United States, 53189
Australia, New South Wales
St. Leonards, New South Wales, Australia, 2065
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Freemantle, Queensland, Australia, 6959
Austria
Graz, Austria, 8036
Salzburg, Austria, 5020
Wien, Austria, 1030
Wien, Austria, 1130
Wien, Austria, 1080
Belgium
Arlon, Belgium, 6700
Bonheiden, Belgium, 2820
Leuven, Belgium, 3000
Liege, Belgium, 4000
Brazil
Recife, PE, Brazil, 52051-380
Campina Grande do Sul, PR, Brazil, 83430-000
Curitiba, PR, Brazil, 80030-110
Porto Alegre, RS, Brazil, 90035-170
Sao Paulo, SP, Brazil, 04022-001
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
Hamilton, Ontario, Canada, L8S 4J9
London, Ontario, Canada, N6A 5R8
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Pointe-Claire, Quebec, Canada, H9R 4S3
Sherbrooke, Quebec, Canada, J1G 5K2
Czech Republic
Brno, Czech Republic, 625 00
Havirov, Czech Republic, 76301
Plzen, Czech Republic, 301 00
Praha, Czech Republic, 180 00
Trutnov, Czech Republic, 541 01
Finland
Helsinki, Finland, 00150
Jyvaeskylae, Finland, 40100
Tampere, Finland, 33100
France
Avignon, France, 84902
Besancon, France, 25030
Bois Guillaume, France, 76233
Brest, France, 29609
Corbeil Essonnes, France, 91106
La Rochelle, France, 17019
Marseille, France, 13015
Marseille, France, 13385
Montpellier, France, 34295
Nimes, France, 30029
Paris, France, 75908
Paris, France, 75877
Paris, France, 75651
Strasbourg, France, 67091
Venissieux, France, 69200
Germany
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
Greece
Athens, Greece, 10552
Larissa, Greece, 41110
Thessaloniki, Greece, 56429
Guatemala
Guatemala, Guatemala, 01010
Hong Kong
Hong Kong, Hong Kong
Hungary
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1045
Szekszard, Hungary, 7100
Italy
Napoli, Campania, Italy, 80100
Roma, Lazio, Italy, 00157
Codogno, Lombardia, Italy, 26845
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20142
Torino, Piemonte, Italy, 10126
Korea, Republic of
Daegu, Korea, Republic of, 700-721
Incheon, Korea, Republic of
Seoul, Korea, Republic of, 137-040
Mexico
Aguascalientes, Mexico, 20127
Cuernavaca, Mexico, 62250
Monterrey, Mexico, 64410
Tampico, Mexico, 89000
New Zealand
Auckland, New Zealand
Auckland, New Zealand, 1640
Peru
Arequipa, Peru, Cercado
Lima, Peru, Lima 33
Lima, Peru, Lima 1
Trujillo, Peru, 13011
Poland
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
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1250-203
Lisboa, Portugal, 1349-019
Puerto Rico
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
Russian Federation
Barnaul, Russian Federation, 656024
Chelyabinsk, Russian Federation, 454136
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 125299
Moscow, Russian Federation, 129110
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, 193012
St. Petersburg, Russian Federation, 194354
Tomsk, Russian Federation, 643050
Serbia
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Nis, Serbia, 18000
Novi Sad, Serbia, 21000
Spain
Pozuelo de alarcon, Madrid, Spain, 28223
Alzira, Valencia, Spain, 46600
Almeria, Spain, 04001
Barcelona, Spain, 08025
Granada, Spain, 18012
Sevilla, Spain, 41013
Sevilla, Spain, 41010
Valencia, Spain, 46014
Valencia, Spain, 46010
Valladolid, Spain, 47005
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
United Kingdom
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00755287     History of Changes
Other Study ID Numbers: BC20965, 2008-001855-23
Study First Received: September 17, 2008
Last Updated: August 4, 2014
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
Insulin, Globin Zinc
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014