A Clinical trial to evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy with glimepiride with or without metformi

Phase 3

Completed

• Conditions: Health Condition 1: null- Type II Diabetes Mellitus

• Registration Number: CTRI/2010/091/000078
• Lead Sponsor: Forest Research Institute Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

Age 18 to 85

Inclusion Criteria

To be eligible to participate in the study, patients must meet the following criteria:

1. Be able to understand and provide written informed consent before the conduct of any study-related procedures

2. Be male or female outpatients 18 to 85 years of age, inclusive, at the Screening Visit (Visit 1)

3. Be diagnosed with T2DM at least 3 months before the Screening Visit (Visit 1).Verification of T2DM diagnosis should be made by obtaining documentation or written confirmation from the physician treating the patient?s diabetes.

4. Have a body mass index of 20 to 48 kg/m2 at the Screening Visit (Visit 1)

5. Have received a stable dosage of glimepiride 4 to 6 mg/d alone or in combination with a stable dosage of metformin ≥ 1500 mg/d (or maximally tolerated dose) for at least 6 weeks before the Screening Visit (Visit 1). (Note: If the patient is taking < 1500 mg/d of metformin because of intolerance, the reason for intolerance must be documented. If the patient is taking > 6 mg/d of glimepiride, the dosage should be

reduced to 6 mg/d at the Screening Visit [Visit 1])

OR

Be willing to switch to glimepiride if receiving a stable dose that is at least half the maximal labeled dose of another SU alone or in combination with a stable dosage of metformin ≥ 1500 mg/d (or maximally tolerated dose) for at least 6 weeks before the Screening Visit (Visit 1). See Appendix III and Section 9.4.7.1 for the recommended switch algorithm

OR

Be willing to switch to glimepiride if receiving a stable dose of any OHA other than an SU as monotherapy at the time of the screening visit ( Viisit 1):

?Stable dose of pioglitazone or rosiglitazone means a minimum of 12 weeks.

?Stable dose of any other OHA as monotherapy means a minimum of 6 weeks

OR

Be drug treatment naïve, meaning never having received an OHA or parenteral medication ( insulin or GLP-1 analogue), or if having received an OHA or parenteral medication, been off said OHA or parenteral medication fro a minimum of 6 weeks (12 weeks for pioglitazone or rosiglitazone) before screening visit ( Visit1)

6. Have received a stable dosage of glimepiride 4 to 6 mg/d alone or in combination with a stable dosage of metformin ≥ 1500 mg/d (or maximally tolerated dose) for at least 2 weeks by Visit 2. (Note: If the patient is taking < 1500 mg/d of metformin because of intolerance, the reason for intolerance must be documented)

7. Have an HbA1c value of ≥ 7% and ≤ 10% at the Screening Visit (Visit 1), except for

(1) patients who have been taking glimepiride 4 mg/d alone or in combination with

metformin and (2) patients who have been taking half the maximal dose of another SU alone or in combination with metformin, in which cases HbA1c can be ≥ 7% to ≤ 10.5%. These patients must be willing to switch to glimepiride and uptitrate the glimepiride dose if necessary. See Appendix III for further details on HbA1c levels and glimepiride dose modification

8. Have an HbA1c value of ≥ 7% and ≤ 10% at Visit 4 (value taken at Visit 3)

9. Have an FPG ≤ 270 mg/dL (15 mmol/L) before Visit 2 for patients whose dose of glimepiride is being modified, or who are being switched to glimepiride, during the Screening period. See Appendix III and Section 9.5.1.1 for

Exclusion Criteria

Patients who meet any of the following criteria will not be eligible to participate in the
study:
1. Currently taking more than two oral hypoglycemic agents (OHA)
2. Have been treated with insulin or a GLP-1 analogue or a DPP4 inhibitor as an outpatient within 6 weeks of the Screening Visit (Visit 1)
3. Have type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring T2DM, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis
4. Have elevated blood glucose due to medical treatment or to a concurrent medical condition other than T2DM (eg, hyperadrenocorticalism due to Cushing syndrome [or Cushing disease], pheochromocytoma, acromegaly, hyperthyroidism, other endocrine
disorder that can raise blood glucose)
5. Have skin lesions (eg, discoloration, swelling, atrophy, ulceration), edema states or diabetic foot ulcers considered medically important by the Investigator.
6. Have a history of epilepsy, not including childhood febrile seizures
7. Have a history of hypoglycemic episode requiring glucose, glucagon, orange juice, etc administered by a second person during the 6 months before the Screening Visit
(Visit 1)
8. Have a history of hyperosmolar, hyperglycemic, or nonketotic syndrome during the
6 months before Screening Visit (Visit 1)
9. Have had a stroke, myocardial infarction, symptomatic coronary artery disease, angina, or arrhythmia within 4 weeks before the Screening Visit (Visit 1) or a history of congestive heart failure class III or class IV (according to the New York Heart Association functional classification system)
10. Have a history of or risk factors for acute pancreatitis (eg, alcohol abuse,extreme hypertriglyceridemia[>100mg/dL],multiple small gallstones) or exacerbation of chronic pancreatitis11. Have a systolic blood pressure (SBP) &#8805; 160 mm Hg or < 90 mm Hg and/or diastolic blood pressure (DBP) &#8805; 100 mm Hg or < 50 mm Hg at the Screening Visit (Visit 1). The measurement at the Screening Visit (Visit 1) can be repeated if the initial reading is felt to be inaccurate or unrepresentative of the patient?s usual blood pressure
12. Have had gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within the year before the Screening Visit (Visit 1) or have plans to have such surgery or procedures for the removal of excess fatty tissue (eg, liposuction or breast reduction) during the course of the study
13. Have started a weight-loss regimen within 4 weeks of the Screening Visit (Visit 1) either on one?s own or by participating in a commercial behavior modification/diet program (eg, Jenny Craig, Weight Watchers) or by taking a medication for weight reduction (eg, phentermine, sibutramine, Xenical/Alli [orlistat])
14. Be currently taking an antipsychotic medication (except prochlorperazine as needed for nausea), have taken systemic glucocorticoids at a dose greater than 5 mg of prednisone or equivalent daily within the 2 weeks before the Screening Visit (Visit 1), or be currently taking products intended to stimulate appetite (eg, megestrol acetate [Megace]). See the Study Reference Manual for prednisone equivalence of other glucocorticoids
15. Have a history of cancer other than treated basal-cell or squamous-cell carcinoma of the skin. (Note: Patients with a history of cancer are allowed provided the malignancy has been in complete remission for at least 5 years before the Screening Visit [Visit 1]. A complet

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1cTimepoint: The primary efficacy <br/ ><br>parameter is the change from baseline in HbA1c at Visit 8

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose (FPG)Timepoint: Change from baseline in FPG till Visit 8.