NCT01698931

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism 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
9

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_4 diabetes

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

April 26, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2003

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

October 1, 2012

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Basal hepatic glucose production

    Day 0; day 44

Secondary Outcomes (3)

  • Number of hypoglycaemic episodes

    Day 0; day 44

  • Change in body weight

    Day 0; day 44

  • Number of adverse events

    Day 0; day 44

Study Arms (3)

Treatment period 1

EXPERIMENTAL
Drug: repaglinideDrug: glyburideDrug: placebo

Treatment period 2

ACTIVE COMPARATOR
Drug: repaglinideDrug: glyburideDrug: placebo

Treatment period 3

PLACEBO COMPARATOR
Drug: repaglinideDrug: glyburideDrug: placebo

Interventions

repaglinideDRUG

1 mg before each main meal on three separate dosing visits separated by a wash-out period

Treatment period 1Treatment period 2Treatment period 3
glyburideDRUG

5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period

Treatment period 1Treatment period 2Treatment period 3
placeboDRUG

Before each main meal on three separate dosing visits separated by a wash-out period

Treatment period 1Treatment period 2Treatment period 3

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • HbA1c (glycosylated haemoglobin A1c) above 7 %
  • BMI (body mass index) below 32 kg/m\^2
  • FBG (fasting blood glucose) after wash out period 130-220 mg/dl
  • Currently treated with diet or OHA (oral hypoglycaemic agent)

You may not qualify if:

  • Current systemic treatment with concomitant medication
  • Known or suspected history of drug or alcohol dependence
  • Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
  • Hepatic disease
  • Cardiac problems
  • Active proliferative retinopathy
  • Known or suspected allergy to trial product or related products
  • Women in fertile age and women having the intention of becoming pregnant
  • Body Mass Index (BMI) above 32 kg/m\^2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Padua, 35137, Italy

Location

Related Publications (1)

  • Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)

    RESULT

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

April 26, 2002

Primary Completion

March 6, 2003

Study Completion

March 6, 2003

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

IT(1)