DiabetesPhase 4NCT00795600

Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

A Phase 4 study testing insulin detemir and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Spain.

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 Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in… 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 and insulin NPH
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: Apr 2009to Aug 2010
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

Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
Body Mass Index (BMI) between 27.5-40 kg/m^2

Who cannot join

Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Receipt of any investigational drug within 1 month prior to this trial
Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection

Trial locations and contacts

1 site in 1 country.

Spain1 site

Study site
Málaga, 29009

Other trials in Spain

About this study

Official title: A Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, Both With Insulin Aspart at Mealtimes

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir, insulin NPH
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
Insulin detemir once daily plus insulin aspart at mealtime
insulin NPHDrug
Insulin NPH once daily plus insulin aspart at mealtime

Study groups in NCT00795600
Study group	Role	What they receive
insulin detemir	Experimental	Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks Receives: Drug: insulin detemir
insulin NPH	Active comparator	Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks Receives: Drug: insulin NPH

What is being measured

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

Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Measured: week 0, week 26
Absolute Change in Trunk Fat Mass
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Measured: week 0, week 26

Secondary outcomes (54)

Absolute Change in Whole Body Fat Mass
Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Measured: Week 0, week 26
Percentage Change in Whole Body Fat Mass
Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Whole Body Lean Mass
Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.
Measured: Week 0, week 26
Percentage Change in Whole Body Lean Mass
Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Trunk Lean Mass
Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate
Measured: Week 0, week 26
Percentage Change in Trunk Lean Mass
Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Calculated Whole Body Fat Percentage
Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate
Measured: Week 0, week 26
Percentual Change in Calculated Whole Body Fat Percentage
Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Calculated Trunk Fat Percentage
Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate
Measured: Week 0, week 26
Percentual Change in Calculated Trunk Fat Percentage
Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Visceral Adipose Tissue Area
Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate
Measured: Week 0, week 26
Percentage Change in Visceral Adipose Tissue Area
Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Subcutaneous Adipose Tissue Area
Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate
Measured: Week 0, week 26
Percentage Change in Subcutaneous Adipose Tissue Area
Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Measured: Week 0, week 26
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Liver/Spleen Attenuation Ratio
Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.
Measured: Week 0, week 26
Percentage Change in Liver/Spleen Attenuation Ratio
Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in HbA1c (Glycosylated Haemoglobin)
Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Fasting Plasma Glucose (FPG)
Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Adiponectin
Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Total Cholesterol
Measured: Week 0, week 26
Absolute Change in High Density Lipoprotein (HDL) Cholesterol
Measured: Week 0, week 26
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
Measured: Week 0, week 26
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Measured: Week 0, week 26
Absolute Change in Triglycerides
Measured: Week 0, week 26
Absolute Change in Free Fatty Acids
Measured: Week 0, week 26
Absolute Change in Haemoglobin
Measured: Week 0, week 26
Absolute Change in Blood Volume (Haematocrit)
Measured: Week 0, week 26
Absolute Change in Thrombocytes
Measured: Week 0, week 26
Absolute Change in Erythrocytes
Measured: Week 0, week 26
Absolute Change in Leucocytes
Measured: Week 0, week 26
Absolute Change in Lymphocytes
Measured: Week 0, week 26
Absolute Change in Monocytes
Measured: Week 0, week 26
Absolute Change in Neutrophils
Measured: Week 0, week 26
Absolute Change in Eosinophils
Measured: Week 0, week 26
Absolute Change in Basophils
Measured: Week 0, week 26
Absolute Change in Creatinine
Measured: Week 0, week 26
Absolute Change in Creatine Phosphokinase
Measured: Week 0, week 26
Absolute Change in Urea
Measured: Week 0, week 26
Absolute Change in Albumin
Measured: Week 0, week 26
Absolute Change in Bilirubin Total
Measured: Week 0, week 26
Absolute Change in Alanine Aminotransferase (ALAT)
Measured: Week 0, week 26
Absolute Change in Aspartate Aminotransferase (ASAT)
Measured: Week 0, week 26
Absolute Change in Alkaline Phosphatase
Measured: Week 0, week 26
Absolute Change in Sodium
Measured: Week 0, week 26
Absolute Change in Potassium
Measured: Week 0, week 26
Absolute Change in Body Weight
Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.
Measured: Week 0, week 26
Absolute Change in Waist Circumference
Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in Hip Circumference
Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.
Measured: Week 0, week 26
Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
Measured: Week 0, week 26
Number of Hypoglycaemic Episodes
Number of episodes reported during the trial.
Measured: Weeks 0-26
Number of Non-serious Adverse Events
Number of episodes reported during the trial.
Measured: Weeks 0-26

Timeline

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

Apr 2009Aug 2010

First posted21 Nov 2008 (estimated)
Study startApr 2009
Primary completionAug 2010
Study completionAug 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00795600
Sponsor's protocol ID: NN304-3614
Other IDs: 2008-003739-19, 2008
Status last verified: Feb 2016
First submitted: 20 Nov 2008
Last updated: 16 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419

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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Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, Both With Insulin Aspart at Mealtimes
ClinicalTrials.gov ID: NCT00795600
Acronym / sponsor ID: NN304-3614
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 21 Nov 2008 (estimated)
Results: Posted 17 Jun 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
insulin detemir	Experimental	Drug: insulin detemirInsulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
insulin NPH	Active comparator	Drug: insulin NPHInsulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
Body Mass Index (BMI) between 27.5-40 kg/m^2

Key exclusion criteria (7 listed)

Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months

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 detemirInsulin detemir once daily plus insulin aspart at mealtime	Drug	insulin detemir
insulin NPHInsulin NPH once daily plus insulin aspart at mealtime	Drug	insulin NPH

Primary outcome

Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
Time frame: week 0, week 26
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Absolute Change in Trunk Fat Mass
Time frame: week 0, week 26
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.

54 secondary outcomes

Absolute Change in Whole Body Fat Mass
Time frame: Week 0, week 26
Percentage Change in Whole Body Fat Mass
Time frame: Week 0, week 26
Absolute Change in Whole Body Lean Mass
Time frame: Week 0, week 26
Percentage Change in Whole Body Lean Mass
Time frame: Week 0, week 26
Absolute Change in Trunk Lean Mass
Time frame: Week 0, week 26
Percentage Change in Trunk Lean Mass
Time frame: Week 0, week 26
Absolute Change in Calculated Whole Body Fat Percentage
Time frame: Week 0, week 26
Percentual Change in Calculated Whole Body Fat Percentage
Time frame: Week 0, week 26
Absolute Change in Calculated Trunk Fat Percentage
Time frame: Week 0, week 26
Percentual Change in Calculated Trunk Fat Percentage
Time frame: Week 0, week 26
Absolute Change in Visceral Adipose Tissue Area
Time frame: Week 0, week 26
Percentage Change in Visceral Adipose Tissue Area
Time frame: Week 0, week 26
Absolute Change in Subcutaneous Adipose Tissue Area
Time frame: Week 0, week 26
Percentage Change in Subcutaneous Adipose Tissue Area
Time frame: Week 0, week 26
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Time frame: Week 0, week 26
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Time frame: Week 0, week 26
Absolute Change in Liver/Spleen Attenuation Ratio
Time frame: Week 0, week 26
Percentage Change in Liver/Spleen Attenuation Ratio
Time frame: Week 0, week 26
Absolute Change in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, week 26
Absolute Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Absolute Change in Adiponectin
Time frame: Week 0, week 26
Absolute Change in Total Cholesterol
Time frame: Week 0, week 26
Absolute Change in High Density Lipoprotein (HDL) Cholesterol
Time frame: Week 0, week 26
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame: Week 0, week 26
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame: Week 0, week 26
Absolute Change in Triglycerides
Time frame: Week 0, week 26
Absolute Change in Free Fatty Acids
Time frame: Week 0, week 26
Absolute Change in Haemoglobin
Time frame: Week 0, week 26
Absolute Change in Blood Volume (Haematocrit)
Time frame: Week 0, week 26
Absolute Change in Thrombocytes
Time frame: Week 0, week 26
Absolute Change in Erythrocytes
Time frame: Week 0, week 26
Absolute Change in Leucocytes
Time frame: Week 0, week 26
Absolute Change in Lymphocytes
Time frame: Week 0, week 26
Absolute Change in Monocytes
Time frame: Week 0, week 26
Absolute Change in Neutrophils
Time frame: Week 0, week 26
Absolute Change in Eosinophils
Time frame: Week 0, week 26
Absolute Change in Basophils
Time frame: Week 0, week 26
Absolute Change in Creatinine
Time frame: Week 0, week 26
Absolute Change in Creatine Phosphokinase
Time frame: Week 0, week 26
Absolute Change in Urea
Time frame: Week 0, week 26

Results and safety

Results posted to the registry on 17 Jun 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
Insulin Detemir	25	21
Insulin NPH	35	31

Primary outcome: Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)

Time frame: week 0, week 26. Least squares mean (Standard Error). Unit: percent change

Measure	Insulin Detemir n = 22	Insulin NPH n = 32
Value	0.366 (2.785)	1.011 (2.158)

Insulin Detemir vs Insulin NPH: Mean Difference (Final Values): -0.645 (95% CI -7.404 to 6.114), p = 0.849, ANCOVA

Population analysed: Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.

Primary outcome: Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)

Time frame: week 0, week 26. Least squares mean (Standard Error). Unit: percent change

Measure	Insulin Detemir n = 21	Insulin NPH n = 31
Value	0.535 (2.875)	1.126 (2.212)

Insulin Detemir vs Insulin NPH: Mean Difference (Final Values): -0.590 (95% CI -7.588 to 6.407), p = 0.948, ANCOVA

Population analysed: Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.

Primary outcome: Absolute Change in Trunk Fat Mass

Time frame: week 0, week 26. Least squares mean (Standard Error). Unit: grams (g)

Measure	Insulin Detemir n = 22	Insulin NPH n = 32
Value	133.99 (412.88)	-62.37 (320.00)

Insulin Detemir vs Insulin NPH: Mean Difference (Final Values): 196.36 (95% CI -805.8 to 1198.5), p = 0.696, ANCOVA

Population analysed: ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.

Primary outcome: Absolute Change in Trunk Fat Mass

Time frame: week 0, week 26. Least squares mean (Standard Error). Unit: grams (g)

Measure	Insulin Detemir n = 21	Insulin NPH n = 31
Value	153.38 (423.93)	39.43 (327.78)

Insulin Detemir vs Insulin NPH: Mean Difference (Final Values): 192.81 (95% CI -844.0 to 1229.7), p = 0.710, ANCOVA

54 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected in a time span of 26 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Detemir	3 of 24 (12.5%)	18 of 24 (75%)	Not reported
Insulin NPH	3 of 35 (8.6%)	29 of 35 (82.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin detemir and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Spain.

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 3 inclusion and 7 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 17 Jun 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?

Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) (time frame: week 0, week 26). The study lists 2 primary outcomes in all. 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 NCT00795600, which also lists 1 linked publication.

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 16 Mar 2016.