Type 2 DiabetesNCT01232946
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
A study testing liraglutide, insulin detemir and liraglutide plus insulin detemir in people with Type 2 Diabetes, run by Indiana University at 1 site in United States.
Trial summary
27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- liraglutide, insulin detemir and liraglutide plus insulin detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 8 Sep 2017
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetic
- 18-50 years
- BMI > 25kg/m2
- HbA1c 7.0-10.0%
- Treated with up to 2 oral agents
Who cannot join
- Chronic illness or infection (other than diabetes mellitus)
- Known coronary artery disease, structural heart disease or abnormal ECG on screen.
- Treatment with >2 antihypertensive agents or blood pressure >140/95 on two occasions during screening
- History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
- Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
- Current pregnancy
Show all 10Show fewer
- Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
- Known intolerance to GLP-1 agonist
- Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
- Recognized microvascular complications (neuropathy, nephropathy, retinopathy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Clinical Research Center
Indianapolis, Indiana, 46202
About this study
27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).
Read the detailed description
The investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All subjects will undergo an initial standardization of background treatment to metformin 2000 mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once daily each morning, tapering up according to label instructions) and/or detemir (administered twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at the end of this treatment period, under fasting conditions in the morning following that day's treatment injection(s).
- Conditions
- Type 2 Diabetes
- Being tested
- liraglutide, insulin detemir, liraglutide plus insulin detemir
- Keywords
- Diabetes, Myocardial metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Victoza
1.8mg subcutaneous qd for 3 months
insulin detemirDrug
Also called Levemir
5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months
liraglutide plus insulin detemirDrug
Also called Vyctoza plus Levemir
liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Iiraglutide | Experimental | Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment. Receives: Drug: liraglutide |
| insulin detemir | Experimental | Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment. Receives: Drug: insulin detemir |
| Liraglutide plus insulin detemir | Experimental | Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment. Receives: Drug: liraglutide plus insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Glucose Uptake
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Measured: 3 months
Myocardial Fatty Acid Oxidation Rate
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Measured: 3 months
Myocardial Fatty Acid Esterification Rate
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJan 2012
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Kieren Mather, Indiana University
- Investigators
- Kieren J Mather, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232946
- Sponsor's protocol ID
- 1105005578
- Status last verified
- Aug 2019
- First submitted
- 1 Nov 2010
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mather KJ, Considine RV, Hamilton L, Patel NA, Mathias C, Territo W, Goodwill AG, Tune JD, Green MA, Hutchins GD. Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection vs. Insulin Alone in Type 2 Diabetes. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3456-3465. doi: 10.1210/jc.2018-00712.
PubMed 30020461
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
- ClinicalTrials.gov ID
- NCT01232946
- Acronym / sponsor ID
- 1105005578
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Myocardial metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2012
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).
Detailed description
The investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All subjects will undergo an initial standardization of background treatment to metformin 2000 mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once daily each morning, tapering up according to label instructions) and/or detemir (administered twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at the end of this treatment period, under fasting conditions in the morning following that day's treatment injection(s).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iiraglutide | Experimental | Drug: liraglutideType 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment. |
| insulin detemir | Experimental | Drug: insulin detemirType 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment. |
| Liraglutide plus insulin detemir | Experimental | Drug: liraglutide plus insulin detemirType 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 2 diabetic
- 18-50 years
- BMI > 25kg/m2
- HbA1c 7.0-10.0%
- Treated with up to 2 oral agents
Key exclusion criteria (10 listed)
- Chronic illness or infection (other than diabetes mellitus)
- Known coronary artery disease, structural heart disease or abnormal ECG on screen.
- Treatment with >2 antihypertensive agents or blood pressure >140/95 on two occasions during screening
- History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
- Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
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 |
|---|---|---|
| liraglutideAlso: Victoza1.8mg subcutaneous qd for 3 months | Drug | Iiraglutide |
| insulin detemirAlso: Levemir5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months | Drug | insulin detemir |
| liraglutide plus insulin detemirAlso: Vyctoza plus Levemirliraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months. | Drug | Liraglutide plus insulin detemir |
Primary outcome
Myocardial Glucose Uptake
Time frame: 3 months
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Myocardial Fatty Acid Oxidation Rate
Time frame: 3 months
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Myocardial Fatty Acid Esterification Rate
Time frame: 3 months
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30020461Mather KJ, Considine RV, Hamilton L, Patel NA, Mathias C, Territo W, Goodwill AG, Tune JD, Green MA, Hutchins GD. Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection vs. Insulin Alone in Type 2 Diabetes. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3456-3465. doi: 10.1210/jc.2018-00712.
- Individual participant dataSharing planned: No
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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.
Kieren J Mather, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liraglutide, insulin detemir and liraglutide plus insulin detemir in people with Type 2 Diabetes, run by Indiana University at 1 site in United States.
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 5 inclusion and 10 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 7 Aug 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2019). 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?
Myocardial Glucose Uptake (time frame: 3 months). The study lists 3 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 NCT01232946, 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 7 Aug 2019.