A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes - Full Text View

Purpose

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: DPP-IV Inhibitor Drug: Placebo Drug: Metformin	Phase II

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Absolute change from baseline in HbAlc [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	218
Study Completion Date:	October 2006

Arms	Assigned Interventions
1: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid Drug: Metformin As prescribed
2: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid Drug: Metformin As prescribed
3: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid Drug: Metformin As prescribed
4: Placebo Comparator	Drug: Placebo po bid 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;
stable metformin therapy for >=3 months before screening.

Exclusion Criteria:

women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
type 1 diabetes;
any anti-hyperglycemic medication other than metformin in the last 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111631

Show 31 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BM18106
First Received:	May 24, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00111631
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00111631