Efficacy and Safety of Repaglinide and Metformin Combinat... | NCT00491725

Studies
Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

NCT00491725

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 3, 2016Estimated

Enrollment

187Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

repaglinide
metformin

Countries

China

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

Status Module

Record Verification Date

Mar 2016

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

Sep 2005

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Jun 25, 2007

First Submission Date that Met QC Criteria

Jun 25, 2007

First Posted Date

Jun 26, 2007Estimated

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 2, 2016

Last Update Posted Date

Mar 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		after 18 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Post Prandial Plasma Glucose
Fasting Plasma Glucose (FPG)
Safety profile

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes for at least 12 weeks
HbA1c: 8.0-10.0%
Current treatment with OAD on monotheray or OAD on combination therapy
Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Recurrent major hypoglycaemia as judged by the Investigator
Uncontrolled hypertension
Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing	Beijing Municipality	100034	China

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C072379	repaglinide
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided