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A Study of Taspoglutide in Type 2 Diabetic Patients

NCT ID: NCT00811460

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

sc for 4 days

taspoglutide

Intervention Type DRUG

300micrograms/day sc for 2 days

taspoglutide

Intervention Type DRUG

800 micrograms/day sc for 2 days

Interventions

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Placebo

sc for 4 days

Intervention Type DRUG

taspoglutide

300micrograms/day sc for 2 days

Intervention Type DRUG

taspoglutide

800 micrograms/day sc for 2 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2008-003582-97

Identifier Type: -

Identifier Source: secondary_id

BP21844

Identifier Type: -

Identifier Source: org_study_id