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

Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612040
• Other study ID #: NN1250-1835
• Secondary ID: 2007-002474-60
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2008
• Last updated: November 27, 2015
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNorway: Norwegian Medicines AgencySweden: Medical Products AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
• insulin degludec
Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
• insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
• insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Des Moines	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after 16 weeks of treatment	Week 0, Week 16	No
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment	Week 0, Week 16	No
Secondary	Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.	Week 16	No
Secondary	Rate of Major and Minor Hypoglycaemic Episodes	Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.	Week 0 to Week 16 + 5 days follow up	No
Secondary	Rate of Nocturnal Major and Minor Hypoglycaemic Episodes	Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).	Week 0 to Week 16 + 5 days follow up	No
Secondary	Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.	Week 0 to Week 16 + 5 days follow up	No
Secondary	Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)	Laboratory values at screening (Week -1) and at Week 16	Week -1, Week 16	No
Secondary	Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)	Laboratory values at screening (Week -1) and at Week 16	Week -1, Week 16	No
Secondary	Laboratory Safety Parameters (Biochemistry): Serum Creatinine	Laboratory values at screening (Week -1) and at Week 16	Week -1, Week 16	No
Secondary	Vital Signs: Diastolic BP (Blood Pressure)	Values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Vital Signs: Systolic BP (Blood Pressure)	Values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Vital Signs: Pulse	Values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Physical Examination	Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.	Week -1, Week 8, Week 16	No

External Links

•   Clinical Trials at Novo Nordisk