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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: insulin glargine
Drug: insulin degludec
Drug: insulin degludec
Drug: insulin degludec
Drug: metformin
PhasePhase 2
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT00611884
First ReceivedJanuary 29, 2008
Last UpdatedMarch 26, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateJanuary 29, 2008
Last Updated DateMarch 26, 2014
Start DateJanuary 2008
Estimated Primary Completion DateAugust 2008
Current Primary Outcome MeasuresChange in Glycosylated Haemoglobin (HbA1c) [Time Frame: Week 0, Week 16] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [Time Frame: Week 16] [Designated as safety issue: No]
  • Rate of Major and Minor Hypoglycaemic Episodes [Time Frame: Week 0 to Week 16 + 5 days follow up] [Designated as safety issue: No]
  • Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [Time Frame: Week 0 to Week 16 + 5 days follow up] [Designated as safety issue: No]
  • Rate of Treatment Emergent Adverse Events (AEs) [Time Frame: Week 0 to Week 16 + 5 days follow up] [Designated as safety issue: No]
  • Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [Time Frame: Week -4, Week 16] [Designated as safety issue: No]
  • Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [Time Frame: Week -4, Week 16] [Designated as safety issue: No]
  • Laboratory Safety Parameters (Biochemistry): Serum Creatinine [Time Frame: Week -4, Week 16] [Designated as safety issue: No]
  • Vital Signs: Diastolic Blood Pressure (BP) [Time Frame: Week 0, Week 16] [Designated as safety issue: No]
  • Vital Signs: Systolic Blood Pressure (BP) [Time Frame: Week 0, Week 16] [Designated as safety issue: No]
  • Vital Signs: Pulse [Time Frame: Week 0, Week 16] [Designated as safety issue: No]
  • Physical examination [Time Frame: Week -4, Week 0, Week 8, Week 16] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Official TitleA 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
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
InterventionDrug: insulin glargine
Treat-to-target dose titration scheme, s.c. injection.
Drug: insulin degludec
Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
Drug: insulin degludec
Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
Drug: insulin degludec
Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
Drug: metformin
Tablets, 1500-2000 mg/day
Study Arm (s)
  • Experimental: SIBA (D)
  • Experimental: SIBA (E)
  • Experimental: SIBA (D) M, W, F
  • Active Comparator: IGlar

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment245
Estimated Completion DateAugust 2008
Estimated Primary Completion DateAugust 2008
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada, India, South Africa

Administrative Information[ + expand ][ + ]

NCT Number NCT00611884
Other Study ID NumbersNN1250-1836
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Benedikte J. Lertoft, DVM Novo Nordisk A/S
Verification DateMarch 2014

Locations[ + expand ][ + ]

Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Redlands, California, United States, 92374
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32204
Novo Nordisk Clinical Trial Call Center
Idaho Falls, Idaho, United States, 83404-7542
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60616
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Springfield, Illinois, United States, 62704
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
Novo Nordisk Clinical Trial Call Center
Medford, Oregon, United States, 97504
Novo Nordisk Clinical Trial Call Center
Simpsonville, South Carolina, United States, 29681
Novo Nordisk Clinical Trial Call Center
Johnson City, Tennessee, United States, 37604
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53209
Canada, Ontario
Etobicoke, Ontario, Canada, M9R 4E1
India
Vellore, India, 632004
South Africa, Gauteng
Johannesburg, Gauteng, South Africa, 2001