NCT00491725

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

June 25, 2007

Last Update Submit

March 2, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 18 weeks of treatment

Secondary Outcomes (3)

  • Post Prandial Plasma Glucose

  • Fasting Plasma Glucose (FPG)

  • Safety profile

Interventions

repaglinideDRUG
metforminDRUG

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100034, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinideMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 26, 2007

Study Start

September 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

CN(1)