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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00111670

Purpose

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

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

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Absolute change from baseline in HbAlc [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate [ Time Frame: Week 12 ] [ 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:	291
Study Completion Date:	July 2006

Arms	Assigned Interventions
1: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid or qd
2: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid or qd
3: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid or qd
4: Experimental	Drug: DPP-IV Inhibitor Escalating doses po bid or qd
5: Placebo Comparator	Drug: Placebo po bid or qd

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 diagnosed >=1 month before screening;
no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria:

type 1 diabetes;
type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111670

Show 40 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:	BM18102
Study First Received:	May 24, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00111670
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009