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A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus

This study has been terminated.
(Terminated due to nonclinical safety findings)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01029795
First received: December 9, 2009
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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 participants with diabetes.
  • To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
  • To determine how much LY2599506 should be given to participants.
  • To determine if LY2599506 has an effect on a participant'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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2599506
Drug: Glyburide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.


Secondary Outcome Measures:
  • Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
    Measures the QT interval in the ECG. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

  • Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.

  • Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.

  • Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
    Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

  • Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

  • Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.

  • Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

  • Change From Baseline in the Perceptions About Medications - Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    PAM-D assesses participants' perceptions about their diabetes medications during the past month. Responses ranged from "None of the time," to "All of the time." The sum of all items in the scale equals the scale score, which was linearly transformed to a 0 (least favorable state) to 100 (most favorable state). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

  • Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
    Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBP minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period [ Time Frame: Baseline through 16 weeks ] [ Designated as safety issue: Yes ]
    Hypoglycemia was defined as any time a participant felt s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Change From Baseline in Body Weight at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks [ Time Frame: Baseline, 4 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: Yes ]
    Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: Yes ]
    Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.

  • Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506 [ 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 ]
    The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (PopPK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506 [ 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 ]
    The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (Pop PK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

  • 30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall [ Time Frame: Baseline through 16 weeks ] [ Designated as safety issue: Yes ]
    Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAJ was terminated after enrolling 38 participants. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: Yes ]
    Heart rate was measured in heartbeats per minute. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Mean Morning Dose of LY2599506 During the 12-week Treatment Period [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks. ] [ Designated as safety issue: No ]
    Assigned morning dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period [ Time Frame: Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks. ] [ Designated as safety issue: No ]
    Assigned afternoon dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: No ]
    Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  • Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period [ Time Frame: Baseline through 12 weeks. ] [ Designated as safety issue: No ]
    The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.


Enrollment: 38
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2599506
Combinations of 50-milligram (mg) or 100-mg capsules of LY2599506 or matching placebo capsules (each dose contains at least 1 capsule of active drug). LY2599506 will be administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
Drug: LY2599506
Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks
Other Name: Glucokinase Activator 1
Drug: Placebo
Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks
Active Comparator: Glyburide
Combinations of 2.5-mg capsules of Glyburide or matching placebo capsules (each dose contains at least 1 capsule of active drug). Glyburide will be administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
Drug: Glyburide
Administered po, BID daily prior to morning and evening meals for 12 weeks
Drug: Placebo
Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Heart 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 millimoles per liter [mmol/L], 600 milligrams per deciliter [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.
  • Have a history of seizure disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029795

Locations
Australia, South Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
East Ringwood, Victoria, Australia, 3135
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Heidelberg, Victoria, Australia, 3081
Austria
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Vienna, Austria, 1090
Czech Republic
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Holesov, Czech Republic, 769 01
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Prague, Czech Republic, 140 59
Germany
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Mainz, Germany, 55116
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Neuss, Germany, D-41460
Israel
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Jerusalem, Israel, 91120
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Nahariya, Israel, 22100
Russian Federation
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Rostov-On-Don, Russian Federation, 344022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg, Russian Federation, 191126
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, Spain, 08022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cordoba, Spain, 14004
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dos Hermanas, Spain, 41014
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Teruel, Spain, 44002
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01029795     History of Changes
Other Study ID Numbers: 13272, I2Q-MC-GMAJ
Study First Received: December 9, 2009
Results First Received: September 15, 2011
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Austria: Agency for Health and Food Safety
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glyburide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014