A Study in Patients With Type 2 Diabetes

This study has been withdrawn prior to enrollment.
(Trial terminated no patients were screened or enrolled)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01408095
First received: August 1, 2011
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

The study is designed to see if once daily oral dosing of LY2608204 will help control diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also help to determine the safety of the medication and the most useful doses of the medication.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2608204
Drug: Glimepiride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2608204 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 to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 12 week endpoint in fasting blood glucose [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in average Seven Point Self Monitored Blood Glucose [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint for Oral Glucose Tolerance Test (OGTT) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in Homa-B: Insulin [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in Homa-IR: Insulin [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in Homa-S: Insulin [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in fasting lipids [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in free fatty acids [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in body weight [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycemic Episodes [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants at each dose level up to 12 weeks [ Time Frame: Baseline up to 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum plasma concentration (Cmax) of LY2608204 [ Time Frame: pre-dose, up to 12 hours post-dose ] [ Designated as safety issue: No ]
  • Number of participants with severe hypoglycemic episodes [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: Yes ]
  • Rate of hypoglycemic episodes [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Area under the curve of concentration-time curve for one dosing interval at steady state (AUC0-tau, ss) of LY2608204 [ Time Frame: pre-dose, up to 12 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2608204
80 to 400 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. The starting dose level depends on the participant's HbA1c level measured at Screening. Administered orally, daily for 12 weeks
Drug: LY2608204
Administered orally
Active Comparator: Glimepiride
1 to 6 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. Administered orally, daily for 12 weeks
Drug: Glimepiride
Administered orally

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
  • May be treated with:

    1. Diet and exercise alone or
    2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
    3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
    4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
  • Must have an Hemoglobin A1c value between 7% and 10%
  • Must have a body mass index (BMI) between 20 and 40 kg/m2
  • Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
  • If female, you must not be able to get pregnant
  • Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction

Exclusion Criteria:

  • Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
  • Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
  • Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
  • Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
  • Have cardiac disease with functional status that is New York Heart Association [NYHA] 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, 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 a QTcB (Bazett's-corrected QT interval) interval greater than 450 msec for men or greater than 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
  • Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
  • Are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dL (177 μmol/L) or a calculated creatinine clearance of less than 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
  • Have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
  • Are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
  • 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
  • Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
  • Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
  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: NCT01408095

  Show 38 Study Locations
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 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01408095     History of Changes
Other Study ID Numbers: 14090, I3P-MC-GKBC
Study First Received: August 1, 2011
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by Eli Lilly and Company:
diabetes
glimepiride
diabetes type II
diabetes type 2
Type 2 diabetes
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014