Diabetes Mellitus, Type 2Phase 2NCT01163721

Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy

A Phase 2 study testing Ranolazine in people with Diabetes Mellitus, Type 2, run by Gilead Sciences 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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Ranolazine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 9 sitesUnited States
Study dates: Jun 2010to Nov 2010
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant with T2DM on stable non-insulin antidiabetic therapy in addition to diet and exercise
Body mass index (BMI) ≥ 25 kg/m^2 and ≤ 40 kg/m^2
HbA1c 7 - 11%
Ability and willingness to maintain a complete and accurate Subject Activity Log during the course of the trial
Female of child-bearing potential must have agreed to use effective methods of contraception
Ability to understand and willing to sign written informed consent

Who cannot join

Type 1 Diabetes Mellitus (T1DM)
T2DM with history of or current insulin therapy. Prior use during pregnancy or gestational diabetes was acceptable.
History of ketoacidosis or ketosis-prone diabetes
Clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial
History of a severe episode of hypoglycemia
Change in non-insulin antidiabetic therapy in addition to diet and exercise < 2 months prior to screening

Show all 11Show fewer

Any clinically significant cardiovascular event < 2 months prior to screening
Clinically significant, inadequately controlled or unstable hypertension
Hospitalization < 2 months prior to screening
Major surgery < 3 months prior to screening
Weight loss medication (prescription or non-prescription) < 2 months prior to screening

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

AMCR Institute
Escondido, California, 92026
Midwest Institute For Clinical Research Inc. (MICR)
Indianapolis, Indiana, 46260
National Research Institute (NRI)
Los Angeles, California, 90057
L-MARC Research Center
Louisville, Kentucky, 40213
SeaView Research Inc.
Miami, Florida, 33126
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Rochester Clinical Research (RCR)
Rochester, New York, 14609
Cetero Research
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Exploratory Study to Access the Metabolic Effects of Ranolazine When Added to Ongoing Non-Insulin Antidiabetic Therapy in Subjects With Type 2 Diabetes Mellitus

This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c), and lowering glucose while fasting, and following a meal (postprandial).

Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by HbA1c ≤ 7.5% or > 7.5%. Enrollment was to include no more than two-thirds of participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia.

Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).

Conditions: Diabetes Mellitus, Type 2
Being tested: Ranolazine, Placebo
Keywords: Type 2 diabetes mellitus, T2DM, Ranolazine, Ranexa, HbA1c
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
Also called Ranexa®
Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
PlaceboDrug
Placebo to match ranolazine administered orally twice daily

Study groups in NCT01163721
Study group	Role	What they receive
Ranolazine	Experimental	Participants were randomized to receive ranolazine for 12 weeks. Receives: Drug: Ranolazine
Placebo	Placebo comparator	Participants were randomized to receive placebo to match ranolazine for 12 weeks. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Measured: Baseline to Week 12
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal
2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Measured: Baseline to Week 12
Change From Baseline in Fasting Serum Glucose at Week 12
Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Measured: Baseline to Week 12

Timeline

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

Jun 2010Nov 2010

First posted16 Jul 2010 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01163721
Sponsor's protocol ID: GS-US-259-0107
Status last verified: Jul 2013
First submitted: 14 Jul 2010
Last updated: 23 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Exploratory Study to Access the Metabolic Effects of Ranolazine When Added to Ongoing Non-Insulin Antidiabetic Therapy in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01163721
Acronym / sponsor ID: GS-US-259-0107
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus, T2DM, Ranolazine, Ranexa, HbA1c
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 16 Jul 2010 (estimated)
Results: Posted 23 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Ranolazine	Experimental	Drug: RanolazineParticipants were randomized to receive ranolazine for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboParticipants were randomized to receive placebo to match ranolazine for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participant with T2DM on stable non-insulin antidiabetic therapy in addition to diet and exercise
Body mass index (BMI) ≥ 25 kg/m^2 and ≤ 40 kg/m^2
HbA1c 7 - 11%
Ability and willingness to maintain a complete and accurate Subject Activity Log during the course of the trial
Female of child-bearing potential must have agreed to use effective methods of contraception

Key exclusion criteria (11 listed)

Type 1 Diabetes Mellitus (T1DM)
T2DM with history of or current insulin therapy. Prior use during pregnancy or gestational diabetes was acceptable.
History of ketoacidosis or ketosis-prone diabetes
Clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial
History of a severe episode 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
RanolazineAlso: Ranexa®Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily	Drug	Ranolazine
PlaceboPlacebo to match ranolazine administered orally twice daily	Drug	Placebo

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline to Week 12
HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal
Time frame: Baseline to Week 12
2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.
Change From Baseline in Fasting Serum Glucose at Week 12
Time frame: Baseline to Week 12
Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.

Results and safety

Results posted to the registry on 23 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ranolazine	39	31
Placebo	41	29

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: percent of HbA1c in blood

Measure	Ranolazine n = 39	Placebo n = 39
Value	-0.61 (0.142)	-0.08 (0.142)

Ranolazine vs Placebo: difference in least squares mean (LSM): -0.53 (95% CI -0.93 to -0.13), p = 0.010, ANCOVA

Population analysed: Participants in the Full Analysis Set with available data were analyzed.

Primary outcome: Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: mg/dL

Measure	Ranolazine n = 35	Placebo n = 36
Value	-26.6 (9.88)	-11.2 (9.63)

Ranolazine vs Placebo: difference in LSM: -15.4 (95% CI -41.0 to 10.2), p = 0.234, ANCOVA

Population analysed: Participants in the Full Analysis Set with available data were analyzed.

Primary outcome: Change From Baseline in Fasting Serum Glucose at Week 12

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: mg/dL

Measure	Ranolazine n = 39	Placebo n = 40
Value	2.0 (7.21)	4.5 (6.83)

Ranolazine vs Placebo: difference in least squares mean (LSM): -2.5 (95% CI -21.1 to 16.2), p = 0.794, ANCOVA

Population analysed: Full Analysis Set

Adverse events

Time frame: Baseline through Week 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranolazine	0 of 39 (0%)	12 of 39 (30.8%)	Not reported
Placebo	1 of 41 (2.4%)	15 of 41 (36.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ranolazine in people with Diabetes Mellitus, Type 2, run by Gilead Sciences 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 11 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 23 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 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. 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?

Yes. Results are posted in the registry (first posted 23 Sep 2013). 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 From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 (time frame: Baseline to Week 12). 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?

On the ClinicalTrials.gov record for NCT01163721.

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 23 Sep 2013.