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Type 2 Diabetes MellitusPhase 2NCT02435277

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

A Phase 2 study testing Low Metformin, Mid Metformin and High Metformin in people with Type 2 Diabetes Mellitus, run by NuSirt Biopharma at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Low Metformin, Mid Metformin and High Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
9 sitesUnited States
Study dates
Oct 2014to Jan 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • River Birch Research Alliance

    Blue Ridge, Georgia, 3051313

  • Medical Research South

    Charleston, South Carolina, 29407

  • Catalina Research Institute

    Chino, California, 91710

  • Streling Research Group

    Cincinnati, Ohio, 45219

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism

    Nashville, Tennessee, 37232

  • Palm Beach Research

    Palm Beach, Florida, 33409

  • Meridian Research

    Savannah, Georgia, 31406

  • Meridien Research

    Tampa, Florida, 33606

Other trials in United States

About this study

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 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.

Read the 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]).

Being tested
Low Metformin, Mid Metformin, High Metformin, Metformin
Keywords
Diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low MetforminDrug

    Also called Metformin, L-Leucince, Leucine

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

  • Mid MetforminDrug

    Also called Metformin, Leucine, L-Leucine

    1100 mg L Leucine in combination with 250mg Metformin BID

  • High MetforminDrug

    Also called Metformin, Leucine, L-Leucine

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

  • MetforminDrug

    Also called Metformin, Leucine, L-Leucine

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

Study groups in NCT02435277
Study groupRoleWhat they receive
Low MetforminExperimental3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin
Receives: Drug: Low Metformin
Mid MetforminExperimental3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin
Receives: Drug: Mid Metformin
High MetforminExperimental3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin
Receives: Drug: High Metformin
Metformin MonotherapyActive comparator3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 12 weeks

Secondary outcomes (1)

  1. 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.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionSep 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02435277
Sponsor's protocol ID
NS-0100-01E
Status last verified
Dec 2017
First submitted
13 Apr 2015
Last updated
17 Jan 2018
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Metformin, Mid Metformin and High Metformin in people with Type 2 Diabetes Mellitus, run by NuSirt Biopharma at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02435277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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