Trial Outcomes & Findings for Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy (NCT NCT01163721)

Last Updated: 2013-09-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2013-09-23

Participant Flow

Participants with type 2 diabetes mellitus (T2DM) were enrolled in a total of 9 study sites in the United States. The first participant was screened on 22 June 2010. The last participant observation was on 15 November 2010.

The Safety Analysis Set (n = 80) includes participants who were randomized in the study and received at least one dose of study drug. The Full Analysis Set (n = 79) includes participants who were randomized in the study and received at least one dose of study drug, and had at least one post-baseline efficacy measurement.

Participant milestones

Participant milestones
Measure	Ranolazine Participants were randomized to receive ranolazine for 12 weeks.	Placebo Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Overall Study STARTED	39	41
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	8	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranolazine Participants were randomized to receive ranolazine for 12 weeks.	Placebo Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Overall Study Adverse Event	5	6
Overall Study Withdrawal by Subject	3	4
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranolazine n=39 Participants Participants were randomized to receive ranolazine for 12 weeks.	Placebo n=41 Participants Participants were randomized to receive placebo to match ranolazine for 12 weeks.	Total n=80 Participants Total of all reporting groups
Age Continuous	58 years STANDARD_DEVIATION 10.1 • n=93 Participants	58 years STANDARD_DEVIATION 9.1 • n=4 Participants	58 years STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	25 Participants n=4 Participants	48 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=93 Participants	28 Participants n=4 Participants	53 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	33 participants n=93 Participants	39 participants n=4 Participants	72 participants n=27 Participants
Race/Ethnicity, Customized Black	5 participants n=93 Participants	1 participants n=4 Participants	6 participants n=27 Participants
Race/Ethnicity, Customized Other	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Glycosylated hemoglobin (HbA1c)	8.41 percent HbA1c in blood STANDARD_DEVIATION 1.078 • n=93 Participants	8.51 percent HbA1c in blood STANDARD_DEVIATION 1.163 • n=4 Participants	8.46 percent HbA1c in blood STANDARD_DEVIATION 1.117 • n=27 Participants
2-hour Postprandial Glucose	253.1 mg/dL STANDARD_DEVIATION 57.37 • n=93 Participants	271.5 mg/dL STANDARD_DEVIATION 87.67 • n=4 Participants	262.5 mg/dL STANDARD_DEVIATION 74.57 • n=27 Participants
Fasting Serum Glucose	153.7 mg/dL STANDARD_DEVIATION 43.05 • n=93 Participants	172.7 mg/dL STANDARD_DEVIATION 52.20 • n=4 Participants	163.4 mg/dL STANDARD_DEVIATION 48.60 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

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

Outcome measures

Outcome measures
Measure	Ranolazine n=39 Participants Participants were randomized to receive ranolazine for 12 weeks.	Placebo n=39 Participants Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	-0.61 percent of HbA1c in blood Standard Error 0.142	-0.08 percent of HbA1c in blood Standard Error 0.142

PRIMARY outcome

Timeframe: Baseline to Week 12

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

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.

Outcome measures

Outcome measures
Measure	Ranolazine n=35 Participants Participants were randomized to receive ranolazine for 12 weeks.	Placebo n=36 Participants Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal	-26.6 mg/dL Standard Error 9.88	-11.2 mg/dL Standard Error 9.63

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	Ranolazine n=39 Participants Participants were randomized to receive ranolazine for 12 weeks.	Placebo n=40 Participants Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Change From Baseline in Fasting Serum Glucose at Week 12	2.0 mg/dL Standard Error 7.21	4.5 mg/dL Standard Error 6.83

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ranolazine n=39 participants at risk Participants were randomized to receive ranolazine for 12 weeks.	Placebo n=41 participants at risk Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/39 • Baseline through Week 12	2.4% 1/41 • Baseline through Week 12

Other adverse events

Other adverse events
Measure	Ranolazine n=39 participants at risk Participants were randomized to receive ranolazine for 12 weeks.	Placebo n=41 participants at risk Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Metabolism and nutrition disorders Hypoglycaemia	10.3% 4/39 • Baseline through Week 12	7.3% 3/41 • Baseline through Week 12
Gastrointestinal disorders Diarrhoea	7.7% 3/39 • Baseline through Week 12	7.3% 3/41 • Baseline through Week 12
Metabolism and nutrition disorders Hyperglycaemia	2.6% 1/39 • Baseline through Week 12	12.2% 5/41 • Baseline through Week 12
Nervous system disorders Headache	2.6% 1/39 • Baseline through Week 12	7.3% 3/41 • Baseline through Week 12
Gastrointestinal disorders Nausea	7.7% 3/39 • Baseline through Week 12	2.4% 1/41 • Baseline through Week 12
Gastrointestinal disorders Abdominal pain	5.1% 2/39 • Baseline through Week 12	2.4% 1/41 • Baseline through Week 12
Nervous system disorders Dizziness	7.7% 3/39 • Baseline through Week 12	0.00% 0/41 • Baseline through Week 12
Psychiatric disorders Insomnia	5.1% 2/39 • Baseline through Week 12	2.4% 1/41 • Baseline through Week 12
General disorders Asthenia	5.1% 2/39 • Baseline through Week 12	0.00% 0/41 • Baseline through Week 12

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER