Type 2 Diabetes MellitusPhase 1/2NCT01474083
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
A Phase 1/2 study testing GK1-399 (formerly TTP399) in people with Type 2 Diabetes Mellitus, run by vTv Therapeutics at 11 sites in United States.
Trial summary
The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- GK1-399 (formerly TTP399)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2011to Sep 2012
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female, aged 18 through 75 years at screening.
- Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- On a stable dose of background medication for the treatment of diabetes
- Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)
Who cannot join
- Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Forest Investigative Site 006
Chula Vista, California, 91911
Forest Investigative Site 002
DeLand, Florida, 32720
Forest Investigative Site 009
Little Rock, Arkansas, 72211
Forest Investigative Site 001
Miami, Florida, 33014
Forest Investigative Site 003
Neptune City, New Jersey, 07753
Forest Investigative Site 007
New York, New York, 10029
Forest Investigative Site 010
Overland Park, Kansas, 66212
Forest Investigative site 011
Saint Paul, Minnesota, 55114
Forest Investigative Site 004
San Antonio, Texas, 78209
Forest Investigative Site 005
Springfield, Missouri, 65802
Forest Investigative Site 008
Willingboro, New Jersey, 08046
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GK1-399 in Patients With Type 2 Diabetes Mellitus
The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- GK1-399 (formerly TTP399), Placebo
- Keywords
- Type 2 diabetes mellitus, pharmacokinetics, pharmacodynamics
- 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.
GK1-399 (formerly TTP399)Drug
Treatment A: GK1-399 200 mg. Oral administration, twice per day.
GK1-399 (formerly TTP399)Drug
Treatment B: GK1-399 800 mg. Oral administration, once per day.
GK1-399 (formerly TTP399)Drug
Treatment C: GK1-399 800 mg. Oral administration, twice per day.
PlaceboDrug
Dose-matched placebo. Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| GK1-399, low dose | Experimental | Not described Receives: Drug: GK1-399 (formerly TTP399) |
| GK1-399, high dose, once per day | Experimental | Not described Receives: Drug: GK1-399 (formerly TTP399) |
| GK1-399, high dose, twice per day | Experimental | Not described Receives: Drug: GK1-399 (formerly TTP399) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of GK1-399 from plasma concentrations
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
Measured: 52 time points over a 6 week period
Secondary outcomes (1)
Pharmacodynamic parameters of plasma glucose
Fasting plasma glucose and postprandial plasma glucose
Measured: 52 time points over a 6 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- vTv Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Burstein, Pharm.D., Study director, TransTech Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474083
- Sponsor's protocol ID
- GK1-MS-201
- Status last verified
- Sep 2013
- First submitted
- 15 Nov 2011
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GK1-399 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01474083
- Acronym / sponsor ID
- GK1-MS-201
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- vTv TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GK1-399, low dose | Experimental | Drug: GK1-399 (formerly TTP399) |
| GK1-399, high dose, once per day | Experimental | Drug: GK1-399 (formerly TTP399) |
| GK1-399, high dose, twice per day | Experimental | Drug: GK1-399 (formerly TTP399) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be male or female, aged 18 through 75 years at screening.
- Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- On a stable dose of background medication for the treatment of diabetes
- Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)
Key exclusion criteria (1 listed)
- Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GK1-399 (formerly TTP399)Treatment A: GK1-399 200 mg. Oral administration, twice per day. | Drug | GK1-399, low dose |
| GK1-399 (formerly TTP399)Treatment B: GK1-399 800 mg. Oral administration, once per day. | Drug | GK1-399, high dose, once per day |
| GK1-399 (formerly TTP399)Treatment C: GK1-399 800 mg. Oral administration, twice per day. | Drug | GK1-399, high dose, twice per day |
| PlaceboDose-matched placebo. Oral administration. | Drug | Placebo |
Primary outcome
Pharmacokinetic parameters of GK1-399 from plasma concentrations
Time frame: 52 time points over a 6 week period
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
1 secondary outcome
Pharmacodynamic parameters of plasma glucose
Time frame: 52 time points over a 6 week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Burstein, Pharm.D. study director
TransTech Pharma, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GK1-399 (formerly TTP399) in people with Type 2 Diabetes Mellitus, run by vTv Therapeutics at 11 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 4 inclusion and 1 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 11 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic parameters of GK1-399 from plasma concentrations (time frame: 52 time points over a 6 week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.