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Completed

NCT Number: NCT00614055

Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Alès, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 maximum 14 days within the last 3 months)
  • Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (SPC)
  • HbA1c, 7.0 - 11.0 % (both inclusive)
  • Body Mass Index (BMI), 25.0 - 37.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Metformin contraindication according to local practice
  • Thiazolidinedione (TZD) treatments within the 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) within 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

Treatment and study plan

insulin degludec/insulin aspart

Drug

Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily

insulin glargine

Drug

Treat-to-target dose titration scheme, injection s.c., once daily

metformin

Drug

Tablets, 1500-2000 mg/day

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Week 0, Week 16

    Change from baseline in HbA1c after 16 weeks of treatment

Secondary outcomes

  1. Change in Fasting Plasma Glucose (FPG)

    Time frame: Week 0, Week 16

    Change from baseline in FPG after 16 weeks of treatment

  2. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

    Time frame: Week 16

    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, bedtime, at 4 am and before breakfast.

  3. Rate of Treatment Emergent Adverse Events (AEs)

    Time frame: Week 0 to Week 16 + 5 days follow up

    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.

  4. Rate of Major and Minor Hypoglycaemic Episodes

    Time frame: Week 0 to Week 16 + 5 days follow up

    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.

  5. Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

    Time frame: Week 0 to Week 16 + 5 days follow up

    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).

  6. Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

    Time frame: Week -4, Week 16

    Values at screening (Week -4) and at Week 16

  7. Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

    Time frame: Week -4, Week 16

    Values at screening (Week -4) and at Week 16

  8. Laboratory Safety Parameters (Biochemistry): Serum Creatinine

    Time frame: Week -4, Week 16

    Values at screening (Week -4) and at Week 16

  9. Vital Signs: Diastolic Blood Pressure (BP)

    Time frame: Week 0, Week 16

    Values at baseline (Week 0) and at Week 16

  10. Vital Signs: Systolic Blood Pressure (BP)

    Time frame: Week 0, Week 16

    Values at baseline (Week 0) and at Week 16

  11. Vital Signs: Pulse

    Time frame: Week 0, Week 16

    Values at baseline (Week 0) and at Week 16

  12. Physical Examination

    Time frame: Week 0, Week 8, Week 16

    Physical examination is performed at baseline (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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2008
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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