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A Study of Dose Titration of LY2189265 in Overweight Patients With Type 2 Diabetes Mellitus (EGO)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00630825
First received: February 28, 2008
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring HbA1C change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus Patients.


Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: Placebo
Drug: LY2189265
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Evaluate once weekly injections of LY2189265 (adjusted and non-adjusted doses) compared to placebo on blood glucose as measured by HbA1C change from baseline in overweight patients with Type 2 Diabetes Mellitus [ Time Frame: at 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fasting blood glucose [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: Yes ]
  • Meal test glucose excursion (change in blood glucose to test meal) [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: Yes ]
  • Self-monitoring of blood glucose (SMBG) 8-point profile [ Time Frame: 2 separate days in weeks preceeding baseline visit, week 4, week 8, and at 16 weeks. ] [ Designated as safety issue: Yes ]
  • Body weight and waist circumference [ Time Frame: weight at every clinic visit and waist at baseline and week 16 ] [ Designated as safety issue: Yes ]
  • B-cell function and insulin sensitivity as estimated by the updated Homeostasis Model Assessment tool (HOMA2) [ Time Frame: baseline and at 16 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Patients achieving an HbA1C of < 7% and <, equal to 6.5% [ Time Frame: baseline, week 4,8, and 16 weeks ] [ Designated as safety issue: No ]
  • Evaluate safety/tolerability of LY2189265 compared to placebo; Evaluate symptoms of nausea,vomiting,diarrhea,dyspepsia measured by Visual Analog Scale and Gastroparesis Cardinal Symptom Index questionnaire; Evaluate hypoglycemia, hyperglycemia,lipids [ Time Frame: baseline, week 4,8, and 16 ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics (PK) of LY2189265 and the relationship between LY2189265 exposure and safety measures. [ Time Frame: week 4,8,and 16 ] [ Designated as safety issue: Yes ]
  • To measure and evaluate patient perception of medication effectiveness using the Perceptions about Medications - Diabetes (PAM-D-S) questionnaire. [ Time Frame: baseline, week 4,8, and 16 ] [ Designated as safety issue: Yes ]
  • To test the psychometric properties of the PAM-D-S and to validate its use for future clinical trials. [ Time Frame: baseline, week 4,8 and 16 ] [ Designated as safety issue: Yes ]

Enrollment: 266
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
One weekly subcutaneous placebo injection
Drug: Placebo
once weekly placebo injection subcutaneously
Experimental: 2
0.5/1.0 mg arm: one weekly subcutaneous injection- 0.5 mg for 4 weeks, followed by once weekly subcutaneous injection of 1.0 mg for 12 weeks.
Drug: LY2189265
0.5 to 1.0 mg once weekly subcutaneous injection - 0.5 mg for 4 weeks, followed by once weekly subcutaneous injection 1.0 mg for 12 weeks.
Experimental: 3
1.0 mg arm: once weekly subcutaneous injections 1.0 mg for 16 weeks.
Drug: LY2189265
1.0 mg subcutaneously weekly injection for 16 weeks
Experimental: 4
1.0 to 2.0 mg arm: once weekly subcutaneous injections of 1.0 mg for 4 weeks, followed by once weekly subcutaneous injections of 2.0 mg for 12 weeks.
Drug: LY2189265
1.0 mg subcutaneous injection weekly for 4 weeks followed by 2.0 mg weekly subcutaneous injection for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus > 3 months by history prior to entering the trial,based on disease diagnostic criteria from the ADA.
  • Men or women age 18 or older. Women must have negative pregnancy test and be willing to use birth control during study duration and one month post.
  • Have HbA1C of > 7.0 to < or equal to 10.5% as determined by central laboratory at visit one.
  • Have a BMI (body mass index) between 27 and 40 kg/m2, inclusive.
  • Been on same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinase, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also know as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only),(e.g. Metformin and Glipizide or Metaglip),(e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).

Exclusion Criteria:

  • Have known Type 1 Diabetes Mellitus
  • Have taken GLP-1 or any GLP-1 analog drug (Byetta)
  • Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (PTCA, open heart surgery, or CABG), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to visit 1.
  • Have acute or chronic hepatitis or elevated liver function tests (ALT), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) > 2mg/dL. If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be < than or equal to 1.5 mg/dL.
  • Currently taking prescription or over the counter medications to prevent weight loss (alli).
  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: NCT00630825

  Show 34 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00630825     History of Changes
Other Study ID Numbers: 12068, H9X-MC-GBCJ
Study First Received: February 28, 2008
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014