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An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Low Metformin

Mid Metformin

High Metformin

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has completed Study NS-0100-01, including all procedures required at Study Termination (Day 28/Visit 7) without major protocol deviations
Is male, or female and, if female, meets all of the following criteria:
- Not breastfeeding
- Post-menopausal or negative pregnancy test result (human chorionic gonadotropin, beta subunit [β-hCG]) at Screening (Visit 1) (not required for hysterectomized females)
- If of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and sexually active, must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or a vasectomized partner) during the entire duration of the study.
Is able to read, understand, and sign the informed consent forms (ICF) and if applicable, an authorization to use and disclose protected health information form (consistent with health insurance portability and accountability act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study.

Is undesirable as a study participant as judged by the investigator (e.g., exhibited poor compliance during Study NS-0100-01)
Is expected to require treatment, or if currently on a stable dose, changes to their regimen of the following medications:
- Lipid-lowering agents
- Anti-hypertensive medications
- Thyroid replacement therapy
- Non-steroidal anti-inflammatory agents
Is expected to require or undergo treatment with any of the following medications:
- Antidiabetes medications (with the exception of study medication [i.e., metformin])
- Oral or parenteral steroids.

Sites / Locations

Catalina Research Institute
Palm Beach Research
Meridien Research
River Birch Research Alliance
Meridian Research
Streling Research Group
Medical Research South
Meharry Medical College
Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Low Metformin

Mid Metformin

High Metformin

Metformin Monotherapy

Arm Description

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin

3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.

Outcomes

Primary Outcome Measures

Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations

Change in HbA1c from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E) in subjects receiving various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy.

Secondary Outcome Measures

Change in Fasting Plasma Glucose

Change in fasting plasma glucose from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E). Based on the pre-specified mixed model inferential statistical analysis, there was an apparent dose-dependent relationship for the mean decrease from baseline in fasting plasma glucose for the fixed dose leucine amd metformin combination treatments A, B and C.

Full Information

NCT ID

NCT02435277

First Posted

April 13, 2015

Last Updated

December 18, 2017

Sponsor

NuSirt Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT02435277

Brief Title

An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients

Official Title

An Extension of Protocol NS-0100-01 to Evaluate the Safety and Effect of Various Fixed-Dose Leucine and Metformin Combinations (NS-0100) Versus Standard Metformin Mono-therapy on Glycemic Control in Subjects With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NuSirt Biopharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer term effect (i.e., additional 8 weeks) of various fixed-dose leucine and metformin combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects with type 2 diabetes using HbA1c as the primary endpoint.

Detailed Description

This is a randomized, 8-week, extension of Study NS-0100-01, to evaluate the effect of various fixed-dose (FDC) combinations of leucine and metformin compared to standard metformin monotherapy on glycemic control. Subjects meeting all inclusion criteria and no exclusion criteria for the extension study, including completion of the 4-week treatment period of Study NS-0100-01 [Day 28/Visit 7]), will be eligible to enroll into the extension. During participation in the extension, subjects will continue to receive their assigned treatment based upon the randomization that occurred on Day 1 (Visit 4) of Study NS-0100-0. The study will include a total of 3 visits: Visit 1E (Day 28/Visit 7 of Study NS-0100-01), Visit 2E (Day 56/Week 8), and Visit 3E (Day 84/Week 12). Key assessments at Visit 2E and Visit 3E include HbA1c, fasting plasma glucose, and plasma insulin. In addition, 3-hour standardized meal tests will be performed on Day 28 (as part of the Study Termination [Visit 7] procedures of Study NS-0100-01 prior to enrolling into the extension) and at Study Termination for the extension (Visit 3E [Day 84/Week 12]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Metformin

Arm Type

Experimental

Arm Description

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin

Arm Title

Mid Metformin

Arm Type

Experimental

Arm Description

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin

Arm Title

High Metformin

Arm Type

Experimental

Arm Description

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin

Arm Title

Metformin Monotherapy

Arm Type

Active Comparator

Arm Description

3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.

Intervention Type

Drug

Intervention Name(s)

Low Metformin

Other Intervention Name(s)

Metformin, L-Leucince, Leucine

Intervention Description

1100 mg L Leucine in combination with 125 mg of Metformin BID

Intervention Type

Drug

Intervention Name(s)

Mid Metformin

Other Intervention Name(s)

Metformin, Leucine, L-Leucine

Intervention Description

1100 mg L Leucine in combination with 250mg Metformin BID

Intervention Type

Drug

Intervention Name(s)

High Metformin

Other Intervention Name(s)

Metformin, Leucine, L-Leucine

Intervention Description

1100 mg of L Leucine in combination with 500 mg Metformin BID

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Metformin, Leucine, L-Leucine

Intervention Description

500 mg Metformin BID until day 14 with dose escalation at day 14 to 850 mg Metformin BID

Primary Outcome Measure Information:

Title

Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations

Description

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in Fasting Plasma Glucose

Description

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has completed Study NS-0100-01, including all procedures required at Study Termination (Day 28/Visit 7) without major protocol deviations Is male, or female and, if female, meets all of the following criteria: Not breastfeeding Post-menopausal or negative pregnancy test result (human chorionic gonadotropin, beta subunit [β-hCG]) at Screening (Visit 1) (not required for hysterectomized females) If of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and sexually active, must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or a vasectomized partner) during the entire duration of the study. Is able to read, understand, and sign the informed consent forms (ICF) and if applicable, an authorization to use and disclose protected health information form (consistent with health insurance portability and accountability act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study. Is undesirable as a study participant as judged by the investigator (e.g., exhibited poor compliance during Study NS-0100-01) Is expected to require treatment, or if currently on a stable dose, changes to their regimen of the following medications: Lipid-lowering agents Anti-hypertensive medications Thyroid replacement therapy Non-steroidal anti-inflammatory agents Is expected to require or undergo treatment with any of the following medications: Antidiabetes medications (with the exception of study medication [i.e., metformin]) Oral or parenteral steroids.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orville Kolterman, MD

Organizational Affiliation

Pharmapace

Official's Role

Study Chair

Facility Information:

Facility Name

Catalina Research Institute

City

Chino

State/Province

California

ZIP/Postal Code

91710

Country

United States

Facility Name

Palm Beach Research

City

Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Meridien Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

River Birch Research Alliance

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

3051313

Country

United States

Facility Name

Meridian Research

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Streling Research Group

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Medical Research South

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Meharry Medical College

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37208

Country

United States

Facility Name

Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients

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