NCT00399711|CompletedPhase 3

Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN4440-1794

Study Type

interventional

Target

560

Locations

2 countries

Sites

103

Timeline

RegisteredNov 2006

StartedNov 2006

CompletionNov 2007

Brief Summary

This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

560

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Nov 2006

Geographic Reach

2 countries

103 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

1 year study duration

Study Start

First participant enrolled

November 1, 2006

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed

Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

November 14, 2006

Last Update Submit

February 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c
After 26 weeks of treatment

Secondary Outcomes (8)

Change in 8-point Glucose Profiles
Change in Lipid Profile
Events of hypoglycemia
Safety parameters
Change in Fasting Plasma Glucose
+3 more secondary outcomes

Interventions

repaglinide and metformin combination tabletDRUG

rosiglitazone and metformin combination tabletDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes for at least 3 months
HbA1c between 7.5-11.0% on monotherapy or
HbA1c between 7.0-10.0% on dual therapy
BMI maximum 45 kg/m2

You may not qualify if:

Any clinically significant disease history in the opinion of the investigator
Severe heart disease
Pregnancy

Contact the study team to confirm eligibility.