Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
120

Inclusion Criteria

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
...
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
Men and women between the ages of 30 and 80 years inclusive
BMI ≥ 23 kg/m2
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

Exclusion Criteria

Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
...
Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
Personal history of non-familial medullary thyroid carcinoma (MTC)
Any factor likely to limit adherence to the protocol, in the opinion of investigator
Current anti-diabetic treatment with insulin or a glucagon-like peptide-1 (GLP-1) agonist
Type 1 diabetes or secondary forms of diabetes
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.
History of pancreatitis
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

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
...
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
Men and women between the ages of 30 and 80 years inclusive
BMI ≥ 23 kg/m2
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

Exclusion Criteria

Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
...
Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
Personal history of non-familial medullary thyroid carcinoma (MTC)
Any factor likely to limit adherence to the protocol, in the opinion of investigator
Current anti-diabetic treatment with insulin or a glucagon-like peptide-1 (GLP-1) agonist
Type 1 diabetes or secondary forms of diabetes
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.
History of pancreatitis
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