Comparison of hydroxychloroquine 400 mg daily versus teneligliptin 20 mg once daily using continuous glucose monitoring (CGM) on patients uncontrolled on insulin plus oral therapy: pilot study.

Phase 4

• Registration Number: CTRI/2018/09/015798
• Lead Sponsor: Dr Prakash Diabetes Specility Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Type 2 diabetic patients who were treated with insulin regimen;

Ages eligible for study: 18 years to 70 years;

HbA1c ranging from 7.5%-10.5% when screening and randomizing;

Body mass index ranging from 25 to 35 kg/m2. > 60 Kg body weight.

Exclusion Criteria

Type 1 diabetes,

Severe complications of diabetes,

Any type of diabetic retinopathy and maculopathy or eye abnormalities.

Severe renal and liver dysfunction,

Severe infections,

Pregnant or nursing women and those who might be pregnant,

• Alcoholism,

• Any patients whom the investigators judged to be inappropriate for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Mean (± standard deviation) 24-hour blood glucose level, <br/ ><br>2) mean amplitude of glycemic excursions (MAGE), <br/ ><br>3) Fasting blood glucose level, <br/ ><br>4) Highest postprandial blood glucose level and time, <br/ ><br>5) increase in blood glucose level after each meal, <br/ ><br>6) Area under the curve (AUC) for blood glucose level � 180 mg/dL within 3 hours after each meal, <br/ ><br>7) Area over the curve (AOC) for daily blood glucose level 70 mg/dL. <br/ ><br>Timepoint: 1) Mean (± standard deviation) 24-hour blood glucose level, <br/ ><br>2) mean amplitude of glycemic excursions (MAGE), <br/ ><br>3) Fasting blood glucose level, <br/ ><br>4) Highest postprandial blood glucose level and time, <br/ ><br>5) increase in blood glucose level after each meal, <br/ ><br>6) Area under the curve (AUC) for blood glucose level � 180 mg/dL within 3 hours after each meal, <br/ ><br>7) Area over the curve (AOC) for daily blood glucose level 70 mg/dL. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Changes in HbA1c between two groupsChanges in FPG & PPBG between two groupsChanges in body weight at the end between two groups <br/ ><br>Frequency of hypoglycemia at the end in each group <br/ ><br>Change in Sr. Creatinine. <br/ ><br>Timepoint: 12 weeks