Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00612040
• Date of registration: 25/01/2008
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
• Scientific title: A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes
• Date of first enrolment: January 2008
• Target sample size: 178
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00612040
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Germany, Norway, Sweden, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 1 diabetes for at least one year

- HbA1c 7-11% (both inclusive)

- Treated with insulin for at least six months - any regimen

Exclusion Criteria:

- Any systemic treatment with products which in the Investigator's opinion could
interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 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
that, in the opinion of the Investigator, may confound the results of the trial or
pose additional risk in administering trial product



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 1

Intervention(s)

Drug: insulin aspart

Drug: insulin glargine

Drug: insulin degludec

Primary Outcome(s)

Change in Glycosylated Haemoglobin (HbA1c) [Time Frame: Week 0, Week 16]

Secondary Outcome(s)

Vital Signs: Diastolic BP (Blood Pressure) [Time Frame: Week 0, Week 16]

Rate of Treatment Emergent Adverse Events (AEs) [Time Frame: Week 0 to Week 16 + 5 days follow up]

Rate of Major and Minor Hypoglycaemic Episodes [Time Frame: Week 0 to Week 16 + 5 days follow up]

Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [Time Frame: Week -1, Week 16]

Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [Time Frame: Week 0 to Week 16 + 5 days follow up]

Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [Time Frame: Week -1, Week 16]

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [Time Frame: Week 16]

Physical Examination [Time Frame: Week -1, Week 8, Week 16]

Change in Fasting Plasma Glucose (FPG) [Time Frame: Week 0, Week 16]

Laboratory Safety Parameters (Biochemistry): Serum Creatinine [Time Frame: Week -1, Week 16]

Vital Signs: Systolic BP (Blood Pressure) [Time Frame: Week 0, Week 16]

Vital Signs: Pulse [Time Frame: Week 0, Week 16]

Secondary ID(s)

NN1250-1835

2007-002474-60

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00612040