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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01029795




Registration number
NCT01029795
Ethics application status
Date submitted
9/12/2009
Date registered
10/12/2009
Date last updated
2/12/2011

Titles & IDs
Public title
A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
I2Q-MC-GMAJ
Secondary ID [2] 0 0
13272
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY2599506
Treatment: Drugs - Glyburide
Treatment: Drugs - Placebo

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.

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.


Treatment: Drugs: LY2599506
Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks

Treatment: Drugs: Glyburide
Administered po, BID daily prior to morning and evening meals for 12 weeks

Treatment: Drugs: Placebo
Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks
Timepoint [1] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [2] 0 0
Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks
Timepoint [2] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [3] 0 0
Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks
Timepoint [3] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [5] 0 0
Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks
Timepoint [5] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [6] 0 0
Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks
Timepoint [6] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [7] 0 0
Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks
Timepoint [7] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [8] 0 0
Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks
Timepoint [8] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [9] 0 0
Change From Baseline in the Perceptions About Medications - Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks
Timepoint [9] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [10] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks
Timepoint [10] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [11] 0 0
Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period
Timepoint [11] 0 0
Baseline through 16 weeks
Secondary outcome [12] 0 0
Change From Baseline in Body Weight at 12 Weeks and 16 Weeks
Timepoint [12] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [13] 0 0
Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks
Timepoint [13] 0 0
Baseline, 4 weeks, 12 weeks, 16 weeks
Secondary outcome [14] 0 0
Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period
Timepoint [14] 0 0
Baseline through 12 weeks
Secondary outcome [15] 0 0
Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period
Timepoint [15] 0 0
Baseline through 12 weeks
Secondary outcome [16] 0 0
Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506
Timepoint [16] 0 0
Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12
Secondary outcome [17] 0 0
Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506
Timepoint [17] 0 0
Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12
Secondary outcome [18] 0 0
30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall
Timepoint [18] 0 0
Baseline through 16 weeks
Secondary outcome [19] 0 0
Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks
Timepoint [19] 0 0
Baseline, 12 weeks, 16 weeks
Secondary outcome [20] 0 0
Mean Morning Dose of LY2599506 During the 12-week Treatment Period
Timepoint [20] 0 0
Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.
Secondary outcome [21] 0 0
Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period
Timepoint [21] 0 0
Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.
Secondary outcome [22] 0 0
Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period
Timepoint [22] 0 0
Baseline through 12 weeks
Secondary outcome [23] 0 0
Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period
Timepoint [23] 0 0
Baseline through 12 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
3135 - East Ringwood
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Holesov
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague
Country [4] 0 0
Germany
State/province [4] 0 0
Mainz
Country [5] 0 0
Germany
State/province [5] 0 0
Neuss
Country [6] 0 0
Israel
State/province [6] 0 0
Jerusalem
Country [7] 0 0
Israel
State/province [7] 0 0
Nahariya
Country [8] 0 0
Russian Federation
State/province [8] 0 0
Rostov-On-Don
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Saint Petersburg
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Cordoba
Country [12] 0 0
Spain
State/province [12] 0 0
Dos Hermanas
Country [13] 0 0
Spain
State/province [13] 0 0
Teruel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01029795