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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine; Drug: insulin degludec; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00611884

NN1250-1836

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 4 patient groups

SIBA (D)

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: metformin

Drug: insulin degludec

SIBA (E)

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: metformin

Drug: insulin degludec

SIBA (D) M, W, F

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: metformin

Drug: insulin degludec

IGlar

Active Comparator group

Treatment:

Drug: metformin

Drug: insulin glargine