Clinical trial NCT01068652: Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs
Official title: Effect of 50-week Treatment With Stepwise Insulin Intensification of Basal-bolus Insulin Analogues (Insulin Detemir and Aspart) or Biphasic Insulin Aspart 30 (NovoMix 30) All in Combination With Fixed Dose of Metformin on Glycaemic Control (Measured as HbA1c) in Subjects With Type 2 Diabetes. Open Labelled, Randomized, Two-arm, Parallel Group, Multi-centre, Multi-national Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa. The aim of this clinical trial is to investigate the effect of 50 weeks of treatment with different intensified insulin administrations (all in combination with a fixed dose of metformin) on blood sugar control in subjects with type 2 diabetes inadequately controlled by oral anti-diabetic drugs (OADs).


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)
* Diagnosed type 2 diabetes (WHO 1999 criteria)
* Currently treated with suboptimal daily dose of OADs (mono or combination therapy) for at least 6 months
* Male or female age at least 18 years old
* HbA1c at least 7.0 % and maximum 11.0% for subjects treated with metformin mono-therapy, or maximum 10% for subjects treated with OAD combination therapy
* BMI maximum 40 kg/m\^2
* Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
* Able and willing to be treated with up to 4 insulin injections per day

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Previous participation in this trial. Participation is defined as randomisation
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Participated in another clinical trial and received an investigational drug within the last weeks prior to the present trial
* Impaired hepatic function defined as alanine aminotransferase (ALT) or alkaline phosphatase (ALP) at least 2.5 times upper referenced limit
* Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least 115 mmol/L) for males and at least 1.2 mg/dL (at least 106 mmol/L) for females
* Subject has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association class III and IV)
* Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure at least 180 mmHg or sitting diastolic blood pressure at least 100 mmHg)
* Proliferative retinopathy or macular oedema requiring acute treatment
* Metformin contraindications according to the package insert
* Current treatment with systemic corticosteroids
* Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering study drug to the subject
* Current addiction to alcohol or other addictive substances as determined by the Investigator
* Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the study or use of the glucose monitor
* History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator

Primary outcomes:
measure: Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 50
Secondary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
timeFrame: Week 0, Week 14
measure: Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
timeFrame: Week 0, Week 26
measure: Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
timeFrame: Week 0, Week 38
measure: Change in Glycosylated Haemoglobin (HbA1c) at Week 50
timeFrame: Week 0, Week 50
measure: Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
timeFrame: Week 14
measure: Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
timeFrame: Week 26
measure: Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
timeFrame: Week 38
measure: Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
timeFrame: Week 50
measure: Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
timeFrame: Week 14
measure: Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
timeFrame: Week 26
measure: Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
timeFrame: Week 38
measure: Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
timeFrame: Week 50
measure: Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
timeFrame: Week 14
measure: Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
timeFrame: Week 26
measure: Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
timeFrame: Week 38
measure: Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
timeFrame: Week 50
Other outcomes:
Locations:
city: Ain Témouchent
country: Algeria
facility: Novo Nordisk Investigational Site
city: Alger
country: Algeria
facility: Novo Nordisk Investigational Site
city: Algiers
country: Algeria
facility: Novo Nordisk Investigational Site
city: Constantine
country: Algeria
facility: Novo Nordisk Investigational Site
city: Oran
country: Algeria
facility: Novo Nordisk Investigational Site
city: Setif
country: Algeria
facility: Novo Nordisk Investigational Site
city: Sidi Bel Abbes
country: Algeria
facility: Novo Nordisk Investigational Site
city: Alexandria
country: Egypt
facility: Novo Nordisk Investigational Site
city: Casablanca
country: Morocco
facility: Novo Nordisk Investigational Site
city: Port Elizabeth
country: South Africa
facility: Novo Nordisk Investigational Site
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Vaderbijlpark
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Kimberly
country: South Africa
facility: Novo Nordisk Investigational Site
state: Northern Cape
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Sandton
country: South Africa
facility: Novo Nordisk Investigational Site
city: Tunisia
country: Tunisia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: