MK-0431 Early Phase II Double-blind Study - Type 2 Diabet... | NCT00371007

Studies
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)

NCT00371007

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

126

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks
Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006_028

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2004Actual

Primary Completion Date

Apr 25, 2005Actual

Completion Date

Apr 25, 2005Actual

First Submitted Date

Aug 31, 2006

First Submission Date that Met QC Criteria

Aug 31, 2006

First Posted Date

Sep 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2017

Last Update Posted Date

Apr 4, 2017Actual

Description Module

Brief Summary

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks	Drug
Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks	Drug

Measure	Description	Time Frame
HbA1c, safety and tolerability

Measure	Description	Time Frame
Plasma glucose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have type 2 diabetes mellitus
On diet/exercise therapy

Exclusion Criteria:

Patients have type 1 diabetes mellitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17933414	Background	Nonaka K, Kakikawa T, Sato A, Okuyama K, Fujimoto G, Kato N, Suzuki H, Hirayama Y, Ahmed T, Davies MJ, Stein PP. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Feb;79(2):291-8. doi: 10.1016/j.diabres.2007.08.021. Epub 2007 Oct 22.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000068900	Sitagliptin Phosphate
D000081206	Duration of Therapy

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds