Type 2 Diabetes MellitusNCT01310452
Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After Treatment With Basal Insulin
A study testing insulin detemir and neutral protamine insulin in people with Type 2 Diabetes Mellitus, run by Fudan University at 1 site in China.
Trial summary
Primary objective: To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of treatment with insulin detemir once daily or insulin NPH once daily both with metformin in overweight and obese type 2… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- insulin detemir and neutral protamine insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- 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.)
- Female or male, 18 years≤age≤70years
- Subjects with insulin naïve type 2 diabetes who have been treated with metformin（>1g/d）alone for at least 3 months prior to screening
- 11%≥HbA1c≥7.5% based on analysis from a central laboratory
- 24kg/m2≤BMI≤40kg/m2
- Weight fluctuation<2kg in one month prior to screening
Show all 9Show fewer
- Able and willing to perform self-monitoring of blood glucose.
- Willing to accept basal insulin therapy
- Able to self-inject all required doses of insulin
Who cannot join
- Treatment with any OADs (Oral Antidiabetic Drugs) in the last 6 months, except metformin (subjects currently treated with metformin within the interval of 1000-2000 mg daily may be included in the trial. The dose should have remained unchanged for a period of one month prior to randomisation and should be expected to remain unchanged throughout the trial period).
- Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramine, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, NSAIDs, tricyclic anti-depressants, atypical anti-psychotics).
- Participation in a clinical study of weight control within the last 3 months prior to screening.
- Previous or planned surgical treatment of obesity.
- Any disease or condition (such as renal, hepatic or cardiac) according to the judgment of the Investigator makes the subject unsuitable for participation in the trial.
- Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
Show all 18Show fewer
- Anticipated change in concomitant medication known to interfere with lipid metabolism, such as lipid-lowering drugs.
- Proliferative retinopathy or maculopathy that has required acute treatment within the last six months.
- Uncontrolled hypertension (treated or untreated) as judged by the Investigator
- Known or suspected allergy to trial product(s) or related products.
- Previous participation in this trial. Participation is defined as screened.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
- Receipt of any investigational drug (NPH or insulin detemir) within 1 month prior to this trial.
- Cardiac disease defined according to NYHA class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection.
- History of hypoglycaemic unawareness.
- With mental implant (such as cardiac pacemaker, insulin pump) in vivo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily
Primary objective:
To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of treatment with insulin detemir once daily or insulin NPH once daily both with metformin in overweight and obese type 2 diabetic subjects.
Read more
Secondary objectives:
To compare the two treatments with respect to:
- Efficacy:
- MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
- Change in HbA1c from baseline at 12 and 26 weeks of treatment.
- Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.
- Weight
- Waist and hip circumference
- Safety:
- Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH
- Lipid profile at the start and after 26 weeks of treatment
- Incidence of Adverse events during the trial
- Safety profile as measured by laboratory safety parameters (haematology, biochemistry) and physical examination/vital signs before and at the end of treatment
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- insulin detemir, neutral protamine insulin
- Keywords
- diabetes, basal insulin, metformin, liver fat, visceral fat
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Fatty Liver
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 with metformin
neutral protamine insulinDrug
neutral protamine insulin once daily with metformin
| Study group | Role | What they receive |
|---|---|---|
| neutral protamine insulin, metformin | Active comparator | NPH insulin once daily plus oral metformin twice or thrice daily during 26 weeks Receives: Drug: insulin detemir |
| insulin detemir, metformin | Experimental | Insulin detemir once daily plus oral metformin twice or thrice daily during 26 weeks Receives: Drug: neutral protamine insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in liver fat content and visceral fat mass
To compare the change in liver fat content and visceral fat mass (cm2), assessed by MRS and MRI, after 26 weeks of treatment with insulin detemir or insulin NPH (both with metformin) in overweight and obese type 2 diabetic subjects
Measured: After 26 weeks of treatment
Secondary outcomes (9)
MRI
Abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
Measured: after 26 weeks of treatment
Change in HbA1c
Change in HbA1c from baseline at 12 and 26 weeks of treatment respectively
Measured: from baseline to 12 and 26 weeks of treatment respectively
Change in Fasting plasma glucose
Change in Fasting plasma glucose (FPG) from baseline at 12 and 26 weeks of treatment respectively
Measured: From baseline to 12 and 26 weeks
Weight at every visit
Weight at every visit
Measured: At every visit
Waist and hip circumference at every visit
Waist and hip circumference at every visit
Measured: At every visit
Hypoglycaemia
Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH
Measured: during the 26-week treatment
Lipid profile
Lipid profile at the start and after 26 weeks of treatment
Measured: At the start and after 26 weeks of treatment
Adverse events
Incidence of Adverse events during the trial
Measured: During the trial
Safety profile
Safety profile as measured by laboratory safety parameters (haematology, biochemistry) and physical examination/vital signs before and at the end of treatment
Measured: During the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310452
- Sponsor's protocol ID
- prof gao xin
- Status last verified
- Jun 2010
- First submitted
- 7 Mar 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
PubMed 18945920Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PubMed 9742976Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.
PubMed 18784090Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, Marks JS. Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000 Sep;23(9):1278-83. doi: 10.2337/diacare.23.9.1278.
PubMed 10977060Lean ME, Powrie JK, Anderson AS, Garthwaite PH. Obesity, weight loss and prognosis in type 2 diabetes. Diabet Med. 1990 Mar-Apr;7(3):228-33. doi: 10.1111/j.1464-5491.1990.tb01375.x.
PubMed 2139394Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.
PubMed 21205123Whittingham JL, Havelund S, Jonassen I. Crystal structure of a prolonged-acting insulin with albumin-binding properties. Biochemistry. 1997 Mar 11;36(10):2826-31. doi: 10.1021/bi9625105.
PubMed 9062110Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. doi: 10.1016/j.clinthera.2006.10.020.
PubMed 17157113Mandosi E, Fallarino M, Rossetti M, Gatti A, Morano S. Waist circumference reduction after insulin detemir therapy in type 2 diabetes patients previously treated with NPH. Diabetes Res Clin Pract. 2009 May;84(2):e18-20. doi: 10.1016/j.diabres.2009.02.006. Epub 2009 Mar 17.
PubMed 19297054Semlitsch 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily
- ClinicalTrials.gov ID
- NCT01310452
- Acronym / sponsor ID
- prof gao xin
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, basal insulin, metformin, liver fat, visceral fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2011
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of treatment with insulin detemir once daily or insulin NPH once daily both with metformin in overweight and obese type 2 diabetic subjects.
Secondary objectives:
To compare the two treatments with respect to:
- Efficacy:
- MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
- Change in HbA1c from baseline at 12 and 26 weeks of treatment.
- Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.
- Weight
- Waist and hip circumference
- Safety:
- Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH
- Lipid profile at the start and after 26 weeks of treatment
- Incidence of Adverse events during the trial
- Safety profile as measured by laboratory safety parameters (haematology, biochemistry) and physical examination/vital signs before and at the end of treatment
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neutral protamine insulin, metformin | Active comparator | Drug: insulin detemirNPH insulin once daily plus oral metformin twice or thrice daily during 26 weeks |
| insulin detemir, metformin | Experimental | Drug: neutral protamine insulinInsulin detemir once daily plus oral metformin twice or thrice daily during 26 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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.)
- Female or male, 18 years≤age≤70years
- Subjects with insulin naïve type 2 diabetes who have been treated with metformin（>1g/d）alone for at least 3 months prior to screening
- 11%≥HbA1c≥7.5% based on analysis from a central laboratory
- 24kg/m2≤BMI≤40kg/m2
Key exclusion criteria (18 listed)
- Treatment with any OADs (Oral Antidiabetic Drugs) in the last 6 months, except metformin (subjects currently treated with metformin within the interval of 1000-2000 mg daily may be included in the trial. The dose should have remained unchanged for a period of one month prior to randomisation and should be expected to remain unchanged throughout the trial period).
- Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramine, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, NSAIDs, tricyclic anti-depressants, atypical anti-psychotics).
- Participation in a clinical study of weight control within the last 3 months prior to screening.
- Previous or planned surgical treatment of obesity.
- Any disease or condition (such as renal, hepatic or cardiac) according to the judgment of the Investigator makes the subject unsuitable for participation in the trial.
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 with metformin | Drug | neutral protamine insulin, metformin |
| neutral protamine insulinneutral protamine insulin once daily with metformin | Drug | insulin detemir, metformin |
Primary outcome
The change in liver fat content and visceral fat mass
Time frame: After 26 weeks of treatment
To compare the change in liver fat content and visceral fat mass (cm2), assessed by MRS and MRI, after 26 weeks of treatment with insulin detemir or insulin NPH (both with metformin) in overweight and obese type 2 diabetic subjects
9 secondary outcomes
MRI
Time frame: after 26 weeks of treatment
Change in HbA1c
Time frame: from baseline to 12 and 26 weeks of treatment respectively
Change in Fasting plasma glucose
Time frame: From baseline to 12 and 26 weeks
Weight at every visit
Time frame: At every visit
Waist and hip circumference at every visit
Time frame: At every visit
Hypoglycaemia
Time frame: during the 26-week treatment
Lipid profile
Time frame: At the start and after 26 weeks of treatment
Adverse events
Time frame: During the trial
Safety profile
Time frame: During the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
- Background: PubMed 18945920Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
- Background: PubMed 9742976Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
- Background: PubMed 18784090Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.
- Background: PubMed 10977060Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, Marks JS. Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000 Sep;23(9):1278-83. doi: 10.2337/diacare.23.9.1278.
- Background: PubMed 2139394Lean ME, Powrie JK, Anderson AS, Garthwaite PH. Obesity, weight loss and prognosis in type 2 diabetes. Diabet Med. 1990 Mar-Apr;7(3):228-33. doi: 10.1111/j.1464-5491.1990.tb01375.x.
- Background: PubMed 21205123Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.
- Background: PubMed 9062110Whittingham JL, Havelund S, Jonassen I. Crystal structure of a prolonged-acting insulin with albumin-binding properties. Biochemistry. 1997 Mar 11;36(10):2826-31. doi: 10.1021/bi9625105.
- Background: PubMed 17157113Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. doi: 10.1016/j.clinthera.2006.10.020.
- Background: PubMed 19297054Mandosi E, Fallarino M, Rossetti M, Gatti A, Morano S. Waist circumference reduction after insulin detemir therapy in type 2 diabetes patients previously treated with NPH. Diabetes Res Clin Pract. 2009 May;84(2):e18-20. doi: 10.1016/j.diabres.2009.02.006. Epub 2009 Mar 17.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin detemir and neutral protamine insulin in people with Type 2 Diabetes Mellitus, run by Fudan University at 1 site in China.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 8 Mar 2011. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
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?
The change in liver fat content and visceral fat mass (time frame: After 26 weeks of treatment). 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 NCT01310452, which also lists 10 linked publications.
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 8 Mar 2011.