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This study has been withdrawn prior to enrollment.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
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
Diabetes Mellitus, Type 2
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 April 14, 2014