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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611884
• Other study ID #: NN1250-1836
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2008
• Last updated: October 16, 2015
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthSouth Africa: Medicines Control CouncilUnited States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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 2

Intervention

Drug:
• insulin glargine
Treat-to-target dose titration scheme, s.c. injection.
• insulin degludec
Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
• insulin degludec
Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
• insulin degludec
Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
• metformin
Tablets, 1500-2000 mg/day

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Greensboro	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Idaho Falls	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Kingsport	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Los Angeles	California
United States	Novo Nordisk Clinical Trial Call Center	Medford	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Norfolk	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Redlands	California
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Simpsonville	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Spring Valley	California
United States	Novo Nordisk Clinical Trial Call Center	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  India,  South Africa, 

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	Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Mean of SMPG 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, before 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 05:59 (included).	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)	Mean values at Week -4 and at Week 16	Week -4, Week 16	No
Secondary	Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)	Mean values at Week -4 and at Week 16	Week -4, Week 16	No
Secondary	Laboratory Safety Parameters (Biochemistry): Serum Creatinine	Mean values at Week -4 and at Week 16	Week -4, Week 16	No
Secondary	Vital Signs: Diastolic Blood Pressure (BP)	Mean values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Vital Signs: Systolic Blood Pressure (BP)	Mean values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Vital Signs: Pulse	Mean values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Physical Examination	Physical examination was performed at screening (Week -4), randomisation (Week 0) 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 -4, Week 0, Week 8, Week 16	No

External Links

•   Clinical Trials at Novo Nordisk