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Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

NCT00611884•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
•Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
•Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
•HbA1c 7.0-11.0 % (both inclusive)
•Body Mass Index (BMI) 23-42 kg/m\^2 \[lb/in\^2 x 703\] (both inclusive)

Exclusion Criteria

•Metformin contraindication according to local practice
•Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
•Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
•Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug

Locations (29)

Novo Nordisk Investigational Site

Inglewood, California, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

Redlands, California, United States

Novo Nordisk Investigational Site

Spring Valley, California, United States

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Novo Nordisk Investigational Site

Springfield, Illinois, United States

Novo Nordisk Investigational Site

Greensboro, North Carolina, United States

Key Dates

Start Date

January 1, 2008

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

March 3, 2017

Enrollment

245

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin glargine

DRUG

insulin degludec

DRUG

insulin degludec

DRUG

insulin degludec

DRUG

metformin

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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