DiabetesPhase 4NCT01068652

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

A Phase 4 study testing insulin detemir, insulin aspart and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 19 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin detemir, insulin aspart and biphasic insulin aspart 30
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 403 participants
Where: 19 sitesin 5 countries
Study dates: Mar 2010to May 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

19 sites in 5 countries.

Country

City, postcode or hospital

19 sites in 5 countries

South Africa10 sites

Novo Nordisk Investigational Site
Cape Town, Western Cape, 7945
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4170
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4450
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1812
Novo Nordisk Investigational Site
Kimberly, Northern Cape, 8301
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, 6014
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0002
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0083
Novo Nordisk Investigational Site
Sandton, 2146
Novo Nordisk Investigational Site
Vaderbijlpark, Gauteng, 1900

Other trials in South Africa

Algeria6 sites

Novo Nordisk Investigational Site
Ain Témouchent, 46000
Novo Nordisk Investigational Site
Algiers, 16000
Novo Nordisk Investigational Site
Constantine, 25000
Novo Nordisk Investigational Site
Oran, 31000
Novo Nordisk Investigational Site
Sétif, 19000
Novo Nordisk Investigational Site
Sidi Bel Abbes, 22000

Other trials in Algeria

Egypt1 site

Novo Nordisk Investigational Site
Alexandria, 21131

Other trials in Egypt

Morocco1 site

Novo Nordisk Investigational Site
Casablanca, 20000

Other trials in Morocco

Tunisia1 site

Novo Nordisk Investigational Site
Tunisia, 1053

Other trials in Tunisia

About this study

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

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir, insulin aspart, biphasic insulin aspart 30, metformin
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin detemirDrug
Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin).
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)
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
metforminDrug
1000-2000 mg/day in combination with insulin treatment

Study groups in NCT01068652
Study group	Role	What they receive
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. Receives: Drug: insulin detemir; Drug: insulin aspart; Drug: 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. Receives: Drug: biphasic insulin aspart 30; Drug: metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (16)

Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
Observed mean change from baseline in HbA1c at Week 14 (visit 11)
Measured: Week 0, Week 14
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Observed mean change in from baseline in HbA1c at Week 26 (visit 18)
Measured: Week 0, Week 26
Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
Observed mean change from baseline in HbA1c at Week 38 (visit 25)
Measured: Week 0, Week 38
Change in Glycosylated Haemoglobin (HbA1c) at Week 50
Observed mean change from baseline in HbA1c at Week 50 (visit 32)
Measured: Week 0, Week 50
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)
Measured: Week 14
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)
Measured: Week 26
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)
Measured: Week 38
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)
Measured: Week 50
Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}
Measured: Week 14
Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}
Measured: Week 26
Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.
Measured: Week 38
Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.
Measured: Week 50
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)
Measured: Week 14
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)
Measured: Week 26
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)
Measured: Week 38
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)
Measured: Week 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010May 2012

First posted15 Feb 2010 (estimated)
Study startMar 2010
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068652
Sponsor's protocol ID: INS-3782
Other IDs: U1111-1112-6407
Status last verified: Nov 2016
First submitted: 12 Feb 2010
Last updated: 13 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01068652
Acronym / sponsor ID: INS-3782
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 8 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Detemir + Met	Active comparator	Drug: insulin detemir, Drug: insulin aspart, Drug: metforminIndividually 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.
BIAsp 30 + Met	Active comparator	Drug: biphasic insulin aspart 30, Drug: metforminIndividually 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin detemirInitial dose of 0.1 U/kg once daily, injected s.c. (under the skin).	Drug	Detemir + Met
insulin aspartPending 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)	Drug	Detemir + Met
biphasic insulin aspart 30Initial 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	Drug	BIAsp 30 + Met
metformin1000-2000 mg/day in combination with insulin treatment	Drug	BIAsp 30 + Met, Detemir + Met

Primary outcome

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

16 secondary outcomes

Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
Time frame: Week 0, Week 14
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time frame: Week 0, Week 26
Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
Time frame: Week 0, Week 38
Change in Glycosylated Haemoglobin (HbA1c) at Week 50
Time frame: Week 0, Week 50
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
Time frame: Week 14
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
Time frame: Week 26
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
Time frame: Week 38
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
Time frame: Week 50
Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
Time frame: Week 14
Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
Time frame: Week 26
Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
Time frame: Week 38
Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
Time frame: Week 50
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Time frame: Week 14
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Time frame: Week 26
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Time frame: Week 38
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Time frame: Week 50

Results and safety

Results posted to the registry on 8 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Detemir + Met	200	182
BIAsp 30 + Met	203	188

Primary outcome: Glycosylated Haemoglobin (HbA1c)

Time frame: Week 50. Mean (Standard Error). Unit: percentage of glycosylated haemoglobin

Measure	Detemir + Met n = 191	BIAsp 30 + Met n = 192
Value	7.34 (0.13)	7.23 (0.12)

Detemir + Met vs BIAsp 30 + Met: Mean Difference (Final Values): 0.11 (95% CI -0.12 to 0.34), p = 0.3406, ANCOVA

Population analysed: Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time frame of 0-50 weeks + 2 weeks follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Detemir + Met	13 of 200 (6.5%)	75 of 200 (37.5%)	Not reported
BIAsp 30 + Met	7 of 203 (3.4%)	78 of 203 (38.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

19 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin detemir, insulin aspart and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 19 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in South Africa, Algeria, Egypt, Morocco, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated Haemoglobin (HbA1c) (time frame: Week 50). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068652.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.