Type 2 Diabetes MellitusPhase 1NCT01843127
A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
A Phase 1 study testing Ranolazine and Exenatide in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 3 sites in United States.
Trial summary
To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Ranolazine and Exenatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Sep 2013
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 to 65 years old, inclusive
- Documented history of T2DM for ≥5 years
- Body mass index (BMI) 20.0 to 40.0 kg/m2, inclusive, at Screening
- Stable treatment (≥ 12 weeks) with metformin alone, a sulfonylurea alone, a meglitinide alone, or a combination of metformin with either a sulfonylurea or a meglitinide
- HbA1c ≥ 7.0% and ≤ 10.5%, inclusive, at Screening
- Fasting glucose within specific ranges, at Screening and after 14 +/-2 days of wash-out from prior oral anti-diabetic agents
Show all 10Show fewer
- Fasting serum C-peptide ≥0.8 ng/mL, at Screening
- Estimated glomerular filtration rate (eGFR)≥60 mL/min/1.73 m2
- Ability and willingness to comply with all study procedures during the course of the study, including washout from oral anti-diabetic (OAD) agents approximately 2 weeks prior to Day -2 admission
- Females of childbearing potential must have a negative pregnancy test at Screening and on Day -2 admission and must agree to use highly effective contraception methods from Screening throughout study participation and for 14 days following the last dose of study drug.
Who cannot join
- History of type 1 diabetes mellitus or secondary forms of diabetes
- History of acute diabetes complications
- Recent or significant heart conditions
- Uncontrolled hypertension
- QTc interval > 500 msec by ECG at Screening or on Day -2 admission, a personal or family history of QTc prolongation, congenital long QT syndrome, or use of drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
- History of severe GI disease (e.g., gastroparesis)
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- History of pancreatitis (acute or chronic)
- Current consumption of > 14 alcoholic drinks per week, or more than 4 alcoholic drinks on any one day
- Current regular use of tobacco- or nicotine-containing products in excess of 10 cigarettes per day or equivalent
- History of substance abuse within 12 months prior to Screening
- Significant hepatic disease, including, but not limited to, chronic active hepatitis and liver cirrhosis (Child-Pugh Class A, B, or C)
- History of malignancy within 5 years prior to Screening
- Significant thyroid disease
- Treatment with selected medications, as indicated in the protocol
- Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or its excipients
- Known hypersensitivity or intolerance to GLP-1 mimetics
- Known hypersensitivity or intolerance to acetaminophen
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN)
- Total Bilirubin (TB) > 2 mg/dL
- Hemoglobin < 12 g/dL (for males) or < 11 g/dL (for females)
- Positive for hepatitis B surface antigen
- Positive for anti-hepatitis C virus antibody
- Positive for human immunodeficiency virus-1 (HIV-1) antibody
- Positive urine drug screen
- Positive alcohol test
- Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 500 mL of blood during the 6 weeks prior to Screening
- Females who are pregnant or breastfeeding
- Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol, or would compromise the quality of the clinical study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
SeaView Research, Inc
Miami, Florida, 33126
Translational Research Institute-Florida Hospital
Orlando, Florida, 32804
About this study
Official title: A Phase 1, Randomized, Single-blind, Placebo-controlled, Multiple-dose, Two-sequence, Cross-over Study to Evaluate the Effect of Ranolazine on Glucagon Secretion in Subjects With Type 2 Diabetes Mellitus, Followed by An Open-label, Single Dose, Exenatide Active-control Period
To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes mellitus (T2DM).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Ranolazine, Placebo, Exenatide
- 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.
RanolazineDrug
PlaceboDrug
ExenatideDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Ranolazine, Exenatide | Active comparator | Not described Receives: Drug: Ranolazine; Drug: Placebo; Drug: Exenatide |
| Ranolazine, Placebo, Exenatide | Active comparator | Not described Receives: Drug: Ranolazine; Drug: Placebo; Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT)
Measured: Days 5, 10, and 14
Secondary outcomes (9)
Plasma glucose, serum insulin, and serum C-peptide AUCs during the SMT
Measured: Days 5, 10, and 14
Collapse under Acetaminophen PK
Measured: Days 5 and 10
Area under the plasma acetaminophen concentration-time curve from time 0 to 240 min (AUC0-240 min)
Measured: Days 5 and 10
Collapse all under ranolazine pharmacokinetics (PK)
Measured: Days 5 and 10
Trough plasma ranolazine concentrations (Ctrough)
Measured: Days 5 and 10
Average plasma ranolazine concentration during a dosing interval at steady state (Css,ave)
Measured: Days 5 and 10
Area under the plasma ranolazine concentration-time curve over dosing interval (AUCtau)
Measured: Days 5 and 10
Apparent elimination half-life (t1/2) of ranolazine
Measured: Days 5 and 10
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Measured: From Screening to 7 days after the final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
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.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843127
- Sponsor's protocol ID
- GS-US-259-0165
- Status last verified
- Mar 2014
- First submitted
- 17 Apr 2013
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-blind, Placebo-controlled, Multiple-dose, Two-sequence, Cross-over Study to Evaluate the Effect of Ranolazine on Glucagon Secretion in Subjects With Type 2 Diabetes Mellitus, Followed by An Open-label, Single Dose, Exenatide Active-control Period
- ClinicalTrials.gov ID
- NCT01843127
- Acronym / sponsor ID
- GS-US-259-0165
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Apr 2013 (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.
To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo, Ranolazine, Exenatide | Active comparator | Drug: Ranolazine, Drug: Placebo, Drug: Exenatide |
| Ranolazine, Placebo, Exenatide | Active comparator | Drug: Ranolazine, Drug: Placebo, Drug: Exenatide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, 18 to 65 years old, inclusive
- Documented history of T2DM for ≥5 years
- Body mass index (BMI) 20.0 to 40.0 kg/m2, inclusive, at Screening
- Stable treatment (≥ 12 weeks) with metformin alone, a sulfonylurea alone, a meglitinide alone, or a combination of metformin with either a sulfonylurea or a meglitinide
- HbA1c ≥ 7.0% and ≤ 10.5%, inclusive, at Screening
Key exclusion criteria (28 listed)
- History of type 1 diabetes mellitus or secondary forms of diabetes
- History of acute diabetes complications
- Recent or significant heart conditions
- Uncontrolled hypertension
- QTc interval > 500 msec by ECG at Screening or on Day -2 admission, a personal or family history of QTc prolongation, congenital long QT syndrome, or use of drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
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 |
|---|---|---|
| Ranolazine | Drug | Placebo, Ranolazine, Exenatide, Ranolazine, Placebo, Exenatide |
| Placebo | Drug | Placebo, Ranolazine, Exenatide, Ranolazine, Placebo, Exenatide |
| Exenatide | Drug | Placebo, Ranolazine, Exenatide, Ranolazine, Placebo, Exenatide |
Primary outcome
Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT)
Time frame: Days 5, 10, and 14
9 secondary outcomes
Plasma glucose, serum insulin, and serum C-peptide AUCs during the SMT
Time frame: Days 5, 10, and 14
Collapse under Acetaminophen PK
Time frame: Days 5 and 10
Area under the plasma acetaminophen concentration-time curve from time 0 to 240 min (AUC0-240 min)
Time frame: Days 5 and 10
Collapse all under ranolazine pharmacokinetics (PK)
Time frame: Days 5 and 10
Trough plasma ranolazine concentrations (Ctrough)
Time frame: Days 5 and 10
Average plasma ranolazine concentration during a dosing interval at steady state (Css,ave)
Time frame: Days 5 and 10
Area under the plasma ranolazine concentration-time curve over dosing interval (AUCtau)
Time frame: Days 5 and 10
Apparent elimination half-life (t1/2) of ranolazine
Time frame: Days 5 and 10
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Time frame: From Screening to 7 days after the final dose
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 31 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ranolazine and Exenatide in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 3 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 10 inclusion and 28 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 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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?
Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT) (time frame: Days 5, 10, and 14). 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 31 Mar 2014.