Type 2 Diabetes MellitusPhase 1NCT01546597
Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine
A Phase 1 study testing Metformin and Ranolazine in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin and Ranolazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 2012
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 30 to 65 years old, inclusive
- Documented history of T2DM
- HbA1c = 6.5%-10%, inclusive
- Fasting serum glucose ≤ 270 mg/dL at Screening
- Fasting C-peptide ≥ 1 ng/mL at Screening
- Stable metformin monotherapy (metformin 1000 to 2000 mg total daily dose for at least 4 weeks prior to Screening)
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- Body mass index (BMI) = 25 to 40 kg/m2, inclusive, at Screening
- Creatinine Clearance > 80 mL/min at Screening
- Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug
Who cannot join
- Type 1 Diabetes Mellitus (T1DM)
- Use of insulin therapy < 3 months prior to Screening
- History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
- Clinically significant complications of diabetes
- History of hypoglycemia
- Any non-insulin antidiabetic therapy (other than metformin) < 2 months prior to Screening
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- Any clinically significant cardiovascular event < 2 months prior to Screening
- Clinically significant, inadequately controlled, or unstable hypertension
- Hospitalization < 2 months prior to Screening or major surgery < 3 months prior to Screening
- History of gastrointestinal disease or surgery that could impact drug absorption
- History of substance of alcohol or substance abuse
- Positive urine drug screen for drugs of abuse
- Positive alcohol breath test
- Any other clinically significant existing medical or psychiatric condition or one requiring further evaluation
- Treatment with selected medications
- Hemoglobin < 12 g/dL for males; or < 11 g/dL for females at Screening
- Active thyroid disease (hypo- or hyperthyroidism)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5x upper limits of normal
- QTc interval > 500 msec at Screening
- Females who are pregnant or are breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single Cohort, Four-period Sequential Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).
Read the detailed description
The primary objective of this study is as follows:
- To evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with T2DM.
The secondary objectives of this study are as follows:
- To examine the safety and tolerability of metformin when co administered with ranolazine at steady-state in subjects with T2DM.
- To determine the steady-state PK of ranolazine in subjects with T2DM receiving metformin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Ranolazine
- Keywords
- Metformin, Ranolazine, 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.
MetforminDrug
Also called Glucophase
- Metformin 500 mg bid on Days 1-5
- Metformin 850 mg bid on Days 6-10
- Metformin 500 mg bid on Days 11-15
- Metformin 850 mg bid on Days 16-20
RanolazineDrug
Also called Ranexa
- Ranolazine 1000 mg bid on Days 11-15
- Ranolazine 1000 mg bid on Days 16-20
| Study group | Role | What they receive |
|---|---|---|
| Metformin, Ranolazine | Experimental | Single cohort, 4-period study:
* Period 1, metformin 500 mg bid on Days 1-5
* Period 2, metformin 850 mg bid on Days 6-10
* Period 3, metformin 500 mg bid + ranolazine 1000 mg bid on Days 11-15
* Period 4, metformin 850 mg bid + ranolazine 1000 mg bid on Days 16-20 Receives: Drug: Metformin; Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of metformin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Time to reach maximum observed plasma concentration (Cmax) of metformin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of metformin
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Secondary outcomes (4)
Number of participants with adverse events
Measured: participants will be followed upon signing informed consent until the follow-up phone call, an expected average of 7 weeks
Maximum observed plasma concentration (Cmax) of ranolazine and metabolites
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20
Time to reach maximum observed plasma concentration (Cmax) of ranolazine and metabolites
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20
Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionMar 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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT01546597
- Sponsor's protocol ID
- GS-US-259-0137
- Status last verified
- Jul 2012
- First submitted
- 14 Feb 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Cohort, Four-period Sequential Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01546597
- Acronym / sponsor ID
- GS-US-259-0137
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Metformin, Ranolazine, 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
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Mar 2012 (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 study is to evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).
Detailed description
The primary objective of this study is as follows:
- To evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with T2DM.
The secondary objectives of this study are as follows:
- To examine the safety and tolerability of metformin when co administered with ranolazine at steady-state in subjects with T2DM.
- To determine the steady-state PK of ranolazine in subjects with T2DM receiving metformin.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin, Ranolazine | Experimental | Drug: Metformin, Drug: RanolazineSingle cohort, 4-period study: * Period 1, metformin 500 mg bid on Days 1-5 * Period 2, metformin 850 mg bid on Days 6-10 * Period 3, metformin 500 mg bid + ranolazine 1000 mg bid on Days 11-15 * Period 4, metformin 850 mg bid + ranolazine 1000 mg bid on Days 16-20 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, 30 to 65 years old, inclusive
- Documented history of T2DM
- HbA1c = 6.5%-10%, inclusive
- Fasting serum glucose ≤ 270 mg/dL at Screening
- Fasting C-peptide ≥ 1 ng/mL at Screening
Key exclusion criteria (20 listed)
- Type 1 Diabetes Mellitus (T1DM)
- Use of insulin therapy < 3 months prior to Screening
- History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
- Clinically significant complications of diabetes
- History of hypoglycemia
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 |
|---|---|---|
| MetforminAlso: Glucophase* Metformin 500 mg bid on Days 1-5 * Metformin 850 mg bid on Days 6-10 * Metformin 500 mg bid on Days 11-15 * Metformin 850 mg bid on Days 16-20 | Drug | Metformin, Ranolazine |
| RanolazineAlso: Ranexa* Ranolazine 1000 mg bid on Days 11-15 * Ranolazine 1000 mg bid on Days 16-20 | Drug | Metformin, Ranolazine |
Primary outcome
Maximum observed plasma concentration (Cmax) of metformin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Time to reach maximum observed plasma concentration (Cmax) of metformin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of metformin
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
4 secondary outcomes
Number of participants with adverse events
Time frame: participants will be followed upon signing informed consent until the follow-up phone call, an expected average of 7 weeks
Maximum observed plasma concentration (Cmax) of ranolazine and metabolites
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20
Time to reach maximum observed plasma concentration (Cmax) of ranolazine and metabolites
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20
Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20
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 11 Jul 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin and Ranolazine in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 1 site 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 9 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 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maximum observed plasma concentration (Cmax) of metformin (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20). The study lists 3 primary outcomes in all. 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 11 Jul 2012.