Effect of Repaglinide on Postprandial Lipemia in Type 2 D... | NCT01605773

Studies
Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

NCT01605773

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 20, 2017Actual

Enrollment

51Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

repaglinide
glyburide

Countries

United States

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

Nov 8, 2001

Primary Completion Date

Mar 13, 2003Actual

Completion Date

Mar 13, 2003Actual

First Submitted Date

May 16, 2012

First Submission Date that Met QC Criteria

May 24, 2012

First Posted Date

May 25, 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 the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia 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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
repaglinide	Experimental		Drug: repaglinide
glyburide	Active Comparator		Drug: glyburide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
repaglinide	Drug	Dose individually adjusted and conducted according to labeling	repaglinide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Triglyceride levels post standardised fat tolerance test

Secondary Outcomes

Measure	Description	Time Frame
Incidence of hypoglycemic episodes
Change in HbA1c (glycosylated haemoglobin A1c)
Change in FPG (fasting plasma glucose)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%)
Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%)
Males or non-pregnant, non-lactating females
Subjects should have normal renal function

Exclusion Criteria:

Type 1 or other specific causes of diabetes
Marked symptomatic diabetes
Uncontrolled treated/untreated hypertension
Known or suspected allergy to the trial products or related products

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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		Houston	Texas	77030	United States

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
D005905	Glyburide

Ancestor Terms

ID	Term
D013453	Sulfonylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided