Comparison of Repaglinide and Metformin Administered Alon... | NCT01720290

Studies
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

NCT01720290

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 20, 2017Actual

Enrollment

150Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

repaglinide
metformin
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

Feb 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

Jul 25, 2002Actual

Primary Completion Date

Feb 25, 2003Actual

Completion Date

Feb 25, 2003Actual

First Submitted Date

Oct 31, 2012

First Submission Date that Met QC Criteria

Oct 31, 2012

First Posted Date

Nov 2, 2012Estimated

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

Feb 17, 2017

Last Update Posted Date

Feb 20, 2017Actual

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 compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Rep	Experimental	Drug: repaglinide
Met	Active Comparator	Drug: metformin
Rep + met	Active Comparator	Drug: repaglinide Drug: metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
repaglinide	Drug	Dose individually adjusted	Rep Rep + met

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes

Measure	Description	Time Frame
Fasting blood glucose (FBG)
1-hour post prandial blood glucose (PPBG)
Incidence of hypoglycemic episodes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)
Body Mass Index (BMI) of 21-35 kg/m^2
HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion Criteria:

Treatment with insulin within the last 3 months preceding the trial
Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)
Participation in any other clinical trial within 30 days of screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 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
Novo Nordisk Investigational Site		Beijing	Beijing Municipality	100191	China
Novo Nordisk Investigational Site

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