NCT01605773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Nov 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2001

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2003

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

May 16, 2012

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Triglyceride levels post standardised fat tolerance test

Secondary Outcomes (3)

  • Incidence of hypoglycemic episodes

  • Change in HbA1c (glycosylated haemoglobin A1c)

  • Change in FPG (fasting plasma glucose)

Study Arms (2)

repaglinide

EXPERIMENTAL
Drug: repaglinide

glyburide

ACTIVE COMPARATOR
Drug: glyburide

Interventions

repaglinideDRUG

Dose individually adjusted and conducted according to labeling

repaglinide
glyburideDRUG

Dose individually adjusted and conducted according to labeling

glyburide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinideGlyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 25, 2012

Study Start

November 8, 2001

Primary Completion

March 13, 2003

Study Completion

March 13, 2003

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

US(1)