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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]

I2Q-MC-GMAJ

Secondary ID [2]

13272

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes Mellitus, Type 2

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks

Timepoint [1]

Baseline, 12 weeks

Secondary outcome [1]

Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks

Timepoint [1]

Baseline, 12 weeks, 16 weeks

Secondary outcome [2]

Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks

Timepoint [2]

Baseline, 12 weeks, 16 weeks

Secondary outcome [3]

Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks

Timepoint [3]

Baseline, 12 weeks, 16 weeks

Secondary outcome [4]

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]

Baseline, 12 weeks, 16 weeks

Secondary outcome [5]

Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks

Timepoint [5]

Baseline, 12 weeks, 16 weeks

Secondary outcome [6]

Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks

Timepoint [6]

Baseline, 12 weeks, 16 weeks

Secondary outcome [7]

Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks

Timepoint [7]

Baseline, 12 weeks, 16 weeks

Secondary outcome [8]

Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks

Timepoint [8]

Baseline, 12 weeks, 16 weeks

Secondary outcome [9]

Change From Baseline in the Perceptions About Medications - Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks

Timepoint [9]

Baseline, 12 weeks, 16 weeks

Secondary outcome [10]

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks

Timepoint [10]

Baseline, 12 weeks, 16 weeks

Secondary outcome [11]

Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period

Timepoint [11]

Baseline through 16 weeks

Secondary outcome [12]

Change From Baseline in Body Weight at 12 Weeks and 16 Weeks

Timepoint [12]

Baseline, 12 weeks, 16 weeks

Secondary outcome [13]

Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks

Timepoint [13]

Baseline, 4 weeks, 12 weeks, 16 weeks

Secondary outcome [14]

Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period

Timepoint [14]

Baseline through 12 weeks

Secondary outcome [15]

Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period

Timepoint [15]

Baseline through 12 weeks

Secondary outcome [16]

Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506

Timepoint [16]

Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12

Secondary outcome [17]

Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506

Timepoint [17]

Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12

Secondary outcome [18]

30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall

Timepoint [18]

Baseline through 16 weeks

Secondary outcome [19]

Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks

Timepoint [19]

Baseline, 12 weeks, 16 weeks

Secondary outcome [20]

Mean Morning Dose of LY2599506 During the 12-week Treatment Period

Timepoint [20]

Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.

Secondary outcome [21]

Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period

Timepoint [21]

Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.

Secondary outcome [22]

Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period

Timepoint [22]

Baseline through 12 weeks

Secondary outcome [23]

Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period

Timepoint [23]

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?

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

Recruitment in Australia

Recruitment state(s)

SA,VIC

Recruitment hospital [1]

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]

Recruitment hospital [3]

Recruitment postcode(s) [1]

5112 - Elizabeth Vale

Recruitment postcode(s) [2]

3135 - East Ringwood

Recruitment postcode(s) [3]

3081 - Heidelberg

Recruitment outside Australia

Country [1]

Austria

State/province [1]

Vienna

Country [2]

Czech Republic

State/province [2]

Holesov

Country [3]

Czech Republic

State/province [3]

Prague

Country [4]

Germany

State/province [4]

Mainz

Country [5]

Germany

State/province [5]

Neuss

Country [6]

Israel

State/province [6]

Jerusalem

Country [7]

Israel

State/province [7]

Nahariya

Country [8]

Russian Federation

State/province [8]

Rostov-On-Don

Country [9]

Russian Federation

State/province [9]

Saint Petersburg

Country [10]

Spain

State/province [10]

Barcelona

Country [11]

Spain

State/province [11]

Cordoba

Country [12]

Spain

State/province [12]

Dos Hermanas

Country [13]

Spain

State/province [13]

Teruel

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Eli Lilly and Company

Address

Country

Ethics approval

Ethics application status

Summary

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 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.

Trial website

https://clinicaltrials.gov/study/NCT01029795

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5hours, EST)

Address

Eli Lilly and Company

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01029795

Trial Review

Did you know?

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