NCT01068652|CompletedPhase 4Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

INS-3782U1111-1112-6407

Study Type

interventional

Target

403

Locations

5 countries

Sites

Timeline

RegisteredFeb 2010

StartedMar 2010

CompletionMay 2012

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

403

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Mar 2010

Typical duration for phase_4 diabetes

Geographic Reach

5 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

February 12, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed

14 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed

11 months until next milestone

Results Posted

Study results publicly available

April 8, 2013

Completed

Last Updated

January 13, 2017

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

February 12, 2010

Results QC Date

February 26, 2013

Last Update Submit

November 23, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Glycosylated Haemoglobin (HbA1c)
Estimated mean difference in HbA1c after 50 weeks of treatment
Week 50

Secondary Outcomes (16)

Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
Week 0, Week 14
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Week 0, Week 26
Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
Week 0, Week 38
Change in Glycosylated Haemoglobin (HbA1c) at Week 50
Week 0, Week 50
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
Week 14
+11 more secondary outcomes

Study Arms (2)

Detemir + Met

ACTIVE COMPARATOR

Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached.

Drug: insulin detemirDrug: insulin aspartDrug: metformin

BIAsp 30 + Met

ACTIVE COMPARATOR

Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.

Drug: biphasic insulin aspart 30Drug: metformin

Interventions

insulin detemirDRUG

Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin).

Detemir + Met

insulin aspartDRUG

Pending evaluation of HbA1c every 3 months, insulin aspart was added to the insulin detemir treatment (up to three does daily, injected s.c. (under the skin)

Detemir + Met

biphasic insulin aspart 30DRUG

Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). Pending evaluation of HbA1c every 3 months, the dose will intensified up to 3 doses daily

BIAsp 30 + Met

metforminDRUG

1000-2000 mg/day in combination with insulin treatment

BIAsp 30 + MetDetemir + Met

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.