Adult Subjects With Uncontrolled Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317796
• Other study ID #: BK-MD-201
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2014
• Last updated: September 23, 2016
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Melior Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes

Description:

Objectives

1. To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus

2. To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1 following 28 days of repeat dosing

Design and Outcomes

The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023 in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise therapy.

A subset of subjects per dose group will have additional samples analyzed to measure signs of MLR-1023.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged = 18 - = 75 years

2. Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception

3. BMI ranging from = 20 to = 40 kg/m2

4. Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3)

5. (i) naïve or (ii) currently using and discontinued metformin or (iii) no prior exposure to anti-diabetic agents other than metformin = 6 months prior to screening

Exclusion Criteria:

1. History of Type 1 diabetes

2. History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness.

3. Hospitalizations or Emergency room visits that would impact patient safety or data interpretation:

1. Due to poor glucose control in the 6 months prior to screening or

2. Any bariatric surgical procedures for weight loss.

4. Significant change of body weight (>10%) in the 3 months before screening

5. Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• MLR-1023
Each subject will receive an oral dose of placebo or MLR-1023 once before breakfast and either placebo (placebo and q.d. dose groups) or a second dose of MLR-1023 (b.i.d. dose groups) before dinner for 4 weeks.

Locations

Country	Name	City	State
United States	Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.	USA and South Korea	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Melior Pharmaceuticals	Bukwang Pharmaceutical, Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PPG AUC0-3h in a MMTT between Days 1 and 29.		29 Days	No
Secondary	Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36		36 Days	No
Secondary	Change in fructosamine level from Day 1 to Day 29		29 Days	No
Secondary	Change in fasting insulin from Day 1 to Day 29		29 Days	No
Secondary	Change in glycated albumin from Day 1 to Day 29		29 Days	No
Secondary	Change from Day 1 to Day 29 in insulin sensitivity using HOMA-R (HOMA-R = fasting plasma insulin (mU/l) * fasting plasma glucose (mmol/l) / 22.5)		29 Days	No
Secondary	Changes from Day 1 to Day 29 in beta-cell function using HOMA-B (HOMA-B = 20 * fast- ?ing plasma insulin (mU/l) / [fasting plasma glucose (mmol/l) - 3.5])		29 Days	No
Secondary	Change in HbA1C between Days 1 and Day 29		29 Days	No
Secondary	Changes in LDL-C, HDL-C, TG between Days 1 and Day 29		29 Days	No
Secondary	Change in weight between Days 1 and Day 29		29 Days	No
Secondary	Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29.		29 Days	No