A Study of Taspoglutide in Type 2 Diabetic Patients - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00811460

Purpose

This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes.

Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Taspoglutide IRF Drug: Placebo	Phase I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Crossover, Randomized, Placebo-Controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-Phase Insulin Secretion in Type 2 Diabetic Patients

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Incremental area under insulin concentration time curve relative to basal insulin concentration [ Time Frame: First 10 minutes after glucose bolus ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incremental area under insulin concentration time curve relative to basal insulin concentration [ Time Frame: 10-120 minutes after glucose bolus ] [ Designated as safety issue: No ]
Adverse events, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Experimental	Drug: Taspoglutide IRF 300micrograms/day sc for 2 days Drug: Taspoglutide IRF 800 micrograms/day sc for 2 days Drug: Placebo sc for 4 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-65 years of age;
type 2 diabetes mellitus;
treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion Criteria:

type 1 diabetes mellitus;
type 2 diabetes duration of <3 months;
treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
treatment with insulin for >7 days within 6 months prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811460

Locations

Germany

NEUSS, Germany, 41460

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BP21844, 2008-003582-97
Study First Received:	December 18, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00811460 History of Changes
Health Authority:	Germany:BfArM

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009