NCT01720303

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

3 active sites

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 19, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2003

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

October 31, 2012

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

Secondary Outcomes (2)

  • Change in FBG (Fasting Blood Glucose)

  • Change in body weight

Study Arms (2)

Rep + NPH

EXPERIMENTAL
Drug: repaglinideDrug: isophane human insulin

Premixed insulin/NPH

ACTIVE COMPARATOR
Drug: insulin

Interventions

repaglinideDRUG

2 mg (tablets) before each main meal

Rep + NPH
isophane human insulinDRUG

Injection s.c. (under the skin) at bedtime

Rep + NPH
insulinDRUG

Injection s.c. (under the skin) twice daily

Premixed insulin/NPH

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HbA1c between 7.5 % and 13.0% (both inclusive)
  • Fasting C-peptide above or equal to 0.33 nmol/l
  • BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

You may not qualify if:

  • Medical history of treatment with insulin within the last 6 months
  • Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100101, China

Location

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, 200040, China

Location

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, 200433, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinideInsulin, IsophaneInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

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

October 31, 2012

First Posted

November 2, 2012

Study Start

September 19, 2002

Primary Completion

April 10, 2003

Study Completion

April 10, 2003

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

CN(3)