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Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMITiDegLira)

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ClinicalTrials.gov Identifier: NCT03862716
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: IDegLira Drug: insulin degludec Drug: Metformin Behavioral: Lifestyle Therapy Phase 3

Detailed Description:
This is a multicentre, open-label, randomized controlled trial in 160 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 16-week course of treatment with IDegLira, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with HbA1C<7.3% at the 16 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
Drug: IDegLira
Dose is titrated to achieve fasting normoglycemia
Other Name: insulin degludec / liraglutide

Drug: insulin degludec
In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia.

Drug: Metformin
Dose is titrated to 2000 mg per day or maximal tolerated dose

Behavioral: Lifestyle Therapy
Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving
Other Name: diet and exercise

No Intervention: Standard Care
Standard glycemic care as informed by the current clinical practice guidelines



Primary Outcome Measures :
  1. Proportion of participants achieving drug-free diabetes remission [ Time Frame: 28 weeks after randomization ]
    Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks.


Secondary Outcome Measures :
  1. Proportion of participants achieving drug-free diabetes remission [ Time Frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization ]
  2. Proportion of participants achieving drug-free normoglycemia [ Time Frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization ]
    defined as HbA1C < 6.0% off glucose-lowering agents for at least 12 weeks.

  3. Proportion of participants achieving drug-free diabetes regression [ Time Frame: 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization ]
    defined as HbA1C <7.0% off glucose-lowering agents for at least 12 weeks.


Other Outcome Measures:
  1. the time interval from randomization until any glucose lowering drug is restarted or relapse of hyperglycemia [ Time Frame: Up to week 68 ]
  2. the time interval from the 16 week visit (i.e. when glucose lowering drugs are to be stopped) until any glucose lowering drug is restarted or relapse of hyperglycemia [ Time Frame: Up to week 68 ]
  3. the change in HbA1c [ Time Frame: 16, 28, 40, 52 and 68 week visit as well as the overall change ]
  4. the change in weight [ Time Frame: 16, 28, 40, 52 and 68 week visit as well as the overall change ]
  5. the change in waist circumference [ Time Frame: 16, 28, 40, 52 and 68 week visit as well as the overall change ]
  6. the change in hip circumference [ Time Frame: 16, 28, 40, 52 and 68 week visit as well as the overall change ]
  7. the change in body mass index [ Time Frame: 16, 28, 40, 52 and 68 week visit as well as the overall change ]
  8. the change in coefficient of variation over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear [ Time Frame: from randomization until the 6, 16, 28 and 52 week visit ]
  9. the change in interquartile range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear [ Time Frame: from randomization until the 6, 16, 28 and 52 week visit ]
  10. the change in time range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear [ Time Frame: from randomization until the 6, 16, 28 and 52 week visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. men and women aged 30-80 years;
  2. T2D diagnosed within 5 years
  3. stable T2D drug regimen in the 8 weeks before randomization;
  4. HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose lowering drugs;
  5. body mass index ≥ 23 kg/m2;
  6. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
  7. willingness to wear a continuous glucose monitor on at least 3 occasions;
  8. ability and willingness to self-inject IDegLira and insulin;
  9. provision of informed consent.

Exclusion Criteria:

  1. current use of insulin therapy;
  2. history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
  3. history of end-stage renal disease or eGFR<45 mL/min/1.73 m2 by MDRD formula;
  4. active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times the upper limit of normal at the time of enrolment;
  5. history or clinical suspicion of pancreatitis or medullary thyroid cancer;
  6. diagnosis or first degree relative with Multiple Endocrine Neoplasia Type 2 (MEN2);
  7. history of diabetic retinopathy requiring photocoagulation, injection therapy or vitrectomy;
  8. history of cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including: i. acute coronary syndrome, hospitalization for unstable angina, myocardial infarction, or revascularization with coronary artery bypass grafting or percutaneous coronary intervention; ii. peripheral vascular disease, valvular heart disease, cardiomyopathy, aortic dissection, tachyarrhythmias, bradyarrhythmias, prior stroke or TIA; iii. prior hospitalization for heart failure; or iv. ECG findings concerning for ischemic heart disease (i.e. pathological Q-waves, ST-segment-T-wave abnormalities in contiguous leads, left anterior hemiblock, left bundle branch block, second or third degree atrioventricular block).
  9. history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
  10. history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
  11. history of any major illness with a life expectancy of < 3 years;
  12. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
  13. excessive alcohol intake, acute or chronic;
  14. currently pregnant, or breastfeeding, or not using a reliable method of birth control for the duration of the trial in all females with childbearing potential;
  15. inability to take insulin degludec, liraglutide or metformin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862716


Contacts
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Contact: Stephanie Hall 905-521-2100 ext 40667 stephanie.hall@phri.ca

Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2T 5C7
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Western University
London, Ontario, Canada, N6G 2M1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Population Health Research Institute
Novo Nordisk A/S
Investigators
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Principal Investigator: Zubin Punthakee, MD McMaster University
Study Chair: Hertzel Gerstein, MD McMaster University

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03862716     History of Changes
Other Study ID Numbers: REMITiDegLira
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Population Health Research Institute:
Diabetes
IDegLira
Metformin
Insulin
Diet
Excercise
Lifestyle

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin, Long-Acting
Xultophy
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists