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Type 2 Diabetes MellitusPhase 2NCT01293669

Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus

A Phase 2 study testing TC-6987 in people with Type 2 Diabetes Mellitus, run by Targacept Inc. at 18 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

TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks, numerous metabolic improvements were observed. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
TC-6987
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
18 sitesUnited States
Study dates
Jan 2011to Jan 2012
Phase
Phase 2
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males or postmenopausal/surgically sterile females
  • Being treated for T2DM with oral antidiabetic agents (excluding glitazones)
  • BMI limit ≤ 38
  • Subjects at least 80% compliant on reporting daily SMBG values during washout
  • At the end of washout the subject's fasting SMBG is higher than it was at the start of washout and the fasting SMBG ≤ 280.g treated for T2DM with oral antidiabetic agents (excluding glitazones)

Who cannot join

  • Type 1 diabetes mellitus
  • Severe complications of T2DM (especially diabetic retinopathy imminently requiring treatment for preserving or restoring vision, diabetic neuropathy with symptomatic orthostatic hypotension, urinary retention, gastric stasis, or pedal ulcers)
  • Current treatment with insulin or a glitazone
  • Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors
  • FSH level of < 35 IU/L and a LH level < 25 IU/L except for confirmed surgically sterile women with functioning ovaries
  • Significant cardiovascular diseases (including arrhythmia) or congestive heart failure, or severe ischemic disease within the last 3 months prior to Screening, or evidence of stroke, myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty
Show all 20Show fewer
  • History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, CV, GI, or urological disorder; or diagnosis of major depressive disorder; if stable medical disorder, any medical treatment must be stable for last 2 months prior to Screening
  • History of diabetic ketoacidosis
  • Patients who have an increased red blood cell (RBC) turn-over or thalassemia or anemia
  • Known HIV or history of viral hepatitis type B or C
  • Systemic infection with TB
  • Current or previous use of oral or injectable corticosteroids 3 months prior to screening.
  • Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure > 180 mmHg or a diastolic blood pressure of > 110 mmHg, with or without treatment
  • Subject has had a malignancy in the last 5 years, except for successfully treated basal or squamous cell carcinoma of the skin or of the cervix
  • Subject is receiving chemotherapy
  • Tobacco user within 4 months prior to Screening
  • Smoking cessation therapy within 4 months prior to Screening and/or planned during the study
  • Use of prohibited concomitant medications including psychoactive agents
  • History within 6 months prior to Screening of alcohol abuse or illicit drug abuse
  • Was administered study medication in another clinical trial in the past 3 months prior to Screening

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Associated Pharmaceutical Research Center

    Buena Park, California, 90620

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Ellipsis Research

    Columbia, South Carolina, 29201

  • Providence Health Partners - Center for Research

    Dayton, Ohio, 45439

  • Om Medical

    Henderson, Nevada, 89052

  • Mercury Clinical Research

    Houston, Texas, 77093

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • New Phase Research and Development

    Knoxville, Tennessee, 37923

  • NCA Medical Center

    Mountain Home, Arkansas, 72653

  • PMG Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • MEDEX Healthcare Research, Inc

    New York, New York, 10004

  • Strelitz Diabetes Center, Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Quality Research, Inc.

    San Antonio, Texas, 78209

  • Medex Healthcare Research, Inc

    St Louis, Missouri, 63117

  • Omega Medical Research

    Warwick, Rhode Island, 02888

  • PMG Research of WS

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Phase II Study of Glycemic Control, Safety, Tolerability and Pharmacokinetic Parameters of TC-6987 Monotherapy in Subjects With Type 2 Diabetes Mellitus

TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks, numerous metabolic improvements were observed. Specifically, plasma glucose and triglyceride concentrations declined by approximately 30%; Hb1Ac was reduced by nearly 50%; and TNF-α declined more than 60% relative to control db/db mice Therefore, it appears that TC-6987 could prove beneficial in reducing elevated glucose concentrations in diabetic patients as well as in ameliorating organ damage associated with inflammation, oxidative stress and hyperglycemia.

Read the detailed description

This is a Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, and pharmacokinetic parameters of TC-6987 in subjects with type 2 diabetes mellitus (T2DM). The study is organized into three phases: (a) Screening phase consisting of a 1-week Screening (Week -5)and a 4-week Washout (Week -4 to Day 1); (b) 4-week, Double-Blind Treatment (Day 1 to Week 4) during which subjects are randomized to either TC-6987 (20 mg on Day 1 and 10 mg from Day 2 to Week 4) or placebo; and (c) 2-week Follow-Up (Week 6). Unscheduled visits will be allowed between visits from Washout through Follow-up to evaluate a subject's glycemic status or other safety issues, as required. Subjects will fast overnight for a minimum of 10 hrs and refrain from drinking alcohol 24 hrs prior to each visit.

Being tested
TC-6987, Placebo
Keywords
Type 2 Diabetes, Type 2 Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • TC-6987Drug

    TC-6987-23 (TC-6987 HCl) as experimental treatment: 20 mg loading dose (2 capsules) on Day 1 and 10 mg (1 capsule) on Days 2 to 28 (dose expressed as free base). Each dose will be given once daily.

  • PlaceboDrug

    Matching placebo: Mode of administration: p.o. (microcrystalline cellulose in capsule) given once daily.

Study groups in NCT01293669
Study groupRoleWhat they receive
TC-6987ExperimentalNot described
Receives: Drug: TC-6987
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Changes in fasting plasma glucose (FPG)

    The primary efficacy endpoint will be FPG values obtained at Week 4 compared to Day 1 (baseline). This change from baseline will be analyzed using MMRM techniques with an alpha of 0.10 (one-sided), to examine differences between the TC-6987 and placebo treatment cohorts. This change from baseline will be analyzed using the primary efficacy endpoints for the mITT analysis set. The efficacy analyses based on the Per Protocol (PP) analysis set will be considered secondary.

    Measured: Day 1 and Week 4

Secondary outcomes (4)

  1. Change in FPG from Day 1 (Baseline) at each time point

    Change in FPG from Day 1 (Baseline) compared to weeks 1 and 4

    Measured: Day 1, Week 1 and Week 4

  2. Change in FPG and insulin from Day 1 (Baseline) at each time point

    Change in FPG and insulin from Day 1 (Baseline) compared to weeks 1 and 4

    Measured: Day 1, Week 1 and Week 4

  3. Change in AUC FPG from Day 1 (Baseline) and at Week 4

    Change in AUC FPG from Day 1 (Baseline) compared to weeks 1 and 4

    Measured: Day 1 and Week 4

  4. Change in AUC insulin from Day 1 (Baseline) at Week 4

    Change in AUC insulin from Day 1 (Baseline) compared to week 4

    Measured: Day 1 and Week 4

Timeline

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

  1. First posted10 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01293669
Sponsor's protocol ID
TC-6987-23-CRD-002
Status last verified
Jul 2012
First submitted
9 Feb 2011
Last updated
13 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TC-6987 in people with Type 2 Diabetes Mellitus, run by Targacept Inc. at 18 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 5 inclusion and 20 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in fasting plasma glucose (FPG) (time frame: Day 1 and Week 4). 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 NCT01293669.

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 13 Sep 2013.

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