Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
120

Inclusion Criteria

A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication
BMI ≥ 23 kg/m2
Men and women between the ages of 30 and 80 years inclusive
...
A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication
BMI ≥ 23 kg/m2
Men and women between the ages of 30 and 80 years inclusive
On 0-2 anti-diabetic medications, with no change in dose/regimen in the preceding 4 weeks
Negative pregnancy test at recruitment for all women with childbearing potential
T2DM diagnosed by a physician ≤7 years prior to enrolment

Exclusion Criteria

Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
Type 1 diabetes or secondary forms of diabetes
...
Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
Type 1 diabetes or secondary forms of diabetes
History of pancreatitis
Current anti-diabetic treatment with insulin or a glucagon-like peptide-1 (GLP-1) agonist
Unwillingness to perform capillary glucose monitoring at least 4 times a day during treatment
Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.
Personal history of non-familial medullary thyroid carcinoma (MTC)
History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
Any factor likely to limit adherence to the protocol, in the opinion of investigator
Family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (MTC)
Hypersensitivity to insulin, exenatide, or the formulations of these products

Summary

Conditions
Type 2 Diabetes
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 80 years
Gender
Both males and females

Description

In this open-label, parallel-arm randomized controlled trial, adults with T2DM of ≤7 years duration on 0-2 anti-diabetic medications will be randomized to 8-weeks treatment with either (i) basal insulin glargine, (ii) intensive insulin therapy consisting of glargine and pre-meal insulin lispro, or (...

In this open-label, parallel-arm randomized controlled trial, adults with T2DM of ≤7 years duration on 0-2 anti-diabetic medications will be randomized to 8-weeks treatment with either (i) basal insulin glargine, (ii) intensive insulin therapy consisting of glargine and pre-meal insulin lispro, or (iii) glargine and the GLP-1 agonist exenatide (twice daily). They will then go into a 12-week washout on lifestyle modification only. Beta-cell function will be assessed by determining the Insulin Secretion-Sensitivity Index-2 (ISSI-2) on oral glucose tolerance test (OGTT) performed at baseline, 4-weeks, 8-weeks, and 20-weeks. The primary outcome will be mean beta-cell function (ISSI-2) over the 8-week treatment period.

Inclusion Criteria

A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication
BMI ≥ 23 kg/m2
Men and women between the ages of 30 and 80 years inclusive
...
A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication
BMI ≥ 23 kg/m2
Men and women between the ages of 30 and 80 years inclusive
On 0-2 anti-diabetic medications, with no change in dose/regimen in the preceding 4 weeks
Negative pregnancy test at recruitment for all women with childbearing potential
T2DM diagnosed by a physician ≤7 years prior to enrolment

Exclusion Criteria

Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
Type 1 diabetes or secondary forms of diabetes
...
Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
Type 1 diabetes or secondary forms of diabetes
History of pancreatitis
Current anti-diabetic treatment with insulin or a glucagon-like peptide-1 (GLP-1) agonist
Unwillingness to perform capillary glucose monitoring at least 4 times a day during treatment
Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.
Personal history of non-familial medullary thyroid carcinoma (MTC)
History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
Any factor likely to limit adherence to the protocol, in the opinion of investigator
Family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (MTC)
Hypersensitivity to insulin, exenatide, or the formulations of these products

Tracking Information

NCT #
NCT02194595
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • University of Toronto
Investigators
  • Principal Investigator: Ravi Retnakaran, MD MOUNT SINAI HOSPITAL
  • Ravi Retnakaran, MD MOUNT SINAI HOSPITAL
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