A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus
Tracking InformationStart Date ICMJE | January 2010 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: December 9, 2009) | The mean change in HbA1C from baseline to 12 week endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT01029795 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: December 9, 2009) | - Change in QT interval in electrocardiogram from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
- Change in Homeostasis Model Assessment (HOMA2) from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Change in triglycerides, LDL, HDL, non-HDL cholesterol, total cholesterol and free fatty acids from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
- Changes in European Quality of Life -5 dimension (EuroQol-5 dimension) from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Changes in Diabetes Treatment Satisfaction Questionnaire from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Changes in Adult Low Blood Sugar Survey from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Changes in Diabetes Symptoms Checklist - revised from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Changes in Perceptions about Medications - Diabetes questionnaire from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Change in blood pressure [ Time Frame: Baseline to 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
- Incidence of hypoglycemic episodes, categorise by severity and treatment group from baseline, during 12 weeks of treatment, and during 4 weeks of follow-up period [ Time Frame: Baseline, up to week 12 and 16 weeks ] [ Designated as safety issue: Yes ]
- Change in body weight from baseline to 12 week and 16 week endpoint [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- 7 point self-monitored blood glucose (SMBG) [ Time Frame: Baseline, 4 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Percentage of patients with lipase and amylase measurements by treatment group and study visits above 2-fold upper limits of normal (ULN) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]
- Total and direct bilirubin, Alkaline phosphatase, alanine transaminase(ALT/SGPT), aspartate transaminase(AST/SGOT), gamma-glutamyl transferase (GGT): percentage of patients above 2-, 3-, and 5-fold upper limits of normal (ULN) [ Time Frame: Baseline up to 12 weeks, 16weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetics LY2599506 maximum concentration (Cmax) [ Time Frame: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 ] [ Designated as safety issue: No ]
- Pharmacokinetics LY2599506 area under the concentration-time curve (AUC) [ Time Frame: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 ] [ Designated as safety issue: No ]
- Rate of hypoglycemic episodes per 30 days [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
- Change in heart rate [ Time Frame: Baseline to 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
- Morning dose of LY2599506 [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks. ] [ Designated as safety issue: No ]
- Afternoon dose of LY2599506 [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks. ] [ Designated as safety issue: No ]
- Frequency of dose adjustments [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
- Total daily dose of LY2599506 [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks. ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1)in Type 2 Diabetes Mellitus |
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Official Title ICMJE | A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2599506 Given as Monotherapy or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus |
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Brief Summary | The purpose of this study is to help answer the following research question(s): - To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks.
- To evaluate the safety of LY2599506 in subjects with diabetes.
- To determine if LY2599506 has the ability to control blood sugar in subjects with diabetes.
- To determine how much LY2599506 should be given to subjects.
- To determine if LY2599506 has an effect on a subject's weight.
The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8 week treatment period, and a 4-week follow up period. |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Diabetes Mellitus, Type 2 |
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Intervention ICMJE | - Drug: LY2599506
Administered orally, twice daily prior to morning and evening meals for 12 weeks Other Name: Glucokinase Activator 1 - Drug: Glyburide
Administered orally, twice daily prior to morning and evening meals for 12 weeks - Drug: Placebo
Administered orally, twice daily prior to morning and evening meals for 12 weeks
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Study Arms / Comparison Groups | - LY2599506: Experimental
Combinations of 50 or 100 mg capsules of LY2599506 or matching placebo capsules (each dose contains at least one capsule of active drug). LY2599506 will be administered in escalating doses from 100 mg/day up to 800 mg/day Interventions: - Drug: LY2599506
- Drug: Placebo
- Glyburide: Active Comparator
Combinations of 2.5 mg capsules of Glyburide or matching placebo capsules (each dose contains at least one capsule of active drug). Glyburide will be administered in escalating doses from 5 mg/day up to 20 mg/day Interventions: - Drug: Glyburide
- Drug: Placebo
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Recruitment InformationEstimated Enrollment ICMJE | 192 |
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Estimated Completion Date | March 2011 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Have type 2 diabetes mellitus prior to entering the trial
- Are currently being treated with diet and exercise therapy consistent with the local standards of medical care
- Treated with: Diet and exercise alone or Diet and exercise in combination with a stable dose of metformin for at least 3 months prior to entering the trial or Diet and exercise in combination with a stable dose of sulfonylurea for at least 3 months prior to entering the trial or Diet and exercise in combination with stable doses of metformin and sulfonylurea for at least 3 months prior to entering the trial and have had diabetes for at least 6 years.
- Have an HbA1c value between 7% and 10%
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.
Exclusion Criteria: - Use of insulin or any antidiabetic agent other than metformin or sulfonylurea during the 3 months prior to entering the trial.
- Have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the Investigator, or have undergone gastric bypass or gastric banding surgery.
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- Have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
- Have cardiac disease with functional status that is New York Hearth Association Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
- Have poorly controlled hypertension (that is, mean systolic blood pressure >160 mm/Hg or mean diastolic blood pressure >100 mm/Hg) history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization.
- Have fed or fasting state hypertriglyceridemia (defined as >6.8 mmol/L, 600 mg/dl) at screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or repeated alanine transaminase (ALT) levels >2.5 times the upper limit of the reference range at screening.
- Have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the Investigator at screening.
- Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
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Gender | Both |
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Ages | 18 Years to 70 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: There may be multiple sites in this clinical trial (1-877-CTLILLY(1-877-285-4559) or | (1-317-615-4559) | | |
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Location Countries ICMJE | Australia, Austria, Czech Republic, Germany, Hungary, Israel, Russian Federation, Spain |
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Administrative InformationNCT ID ICMJE | NCT01029795 |
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Responsible Party | Chief Medical Officer, Eli Lilly |
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Study ID Numbers ICMJE | 13272, I2Q-MC-GMAJ |
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Study Sponsor ICMJE | Eli Lilly and Company |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5hours, EST) | Eli Lilly and Company | |
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Information Provided By | Eli Lilly and Company |
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