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Phase 2 Completed N=167 Randomized Triple-blind Treatment

Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

Source: ClinicalTrials.gov NCT00791479 ↗
Enrolled (actual)
167
Serious AEs
2.4%
Results posted
Dec 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) — -0.37; -0.89; -1.03; -1.04 percentage of glycosylated hemoglobin — p=<0.001

Summary

This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
-0.28; -0.51; -0.46; -0.53; -0.01; -0.33 <0.001 sig
SECONDARY
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
-0.28; -0.51; -0.46; -0.53; -0.01; -0.33 <0.001 sig
SECONDARY
Change From Baseline in Fasting Blood Glucose
-11.59; -30.31; -33.73; -37.49; -3.78 <0.001 sig
SECONDARY
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
47.1; 73.3; 75.0; 71.4; 21.4; 14.7 <0.001 sig
SECONDARY
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
-15.77; -32.21; -42.46; -44.79; -6.12 <0.001 sig
SECONDARY
Change From Baseline in Beta-cell Function (HOMA2-%B)
13.18; 31.66; 39.04; 29.29; -2.06 <0.001 sig
SECONDARY
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
-2.41; 6.10; -4.80; 12.98; 0.58 0.450
SECONDARY
Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
1.34; -1.18; 4.56; -0.63; 0.70; 3.22
SECONDARY
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
1.38; 1.16; 1.88; 4.18; 0.67
SECONDARY
Change From Baseline in Pulse Rate
0.19; 0.25; 1.02; 1.34; 1.29
SECONDARY
Change From Baseline in Blood Pressure (BP)
-2.21; 0.51; -2.57; 1.88; -0.68; -0.24
SECONDARY
Number of Participants With Self-reported Hypoglycemic Events
0; 2; 2; 3; 0; 1
SECONDARY
Rate of Self-reported Hypoglycemic Events
-0.08; 0.25; 1.68; 0.61; -0.09; 0.19
SECONDARY
Treatment Emergent Adverse Events
21; 17; 20; 18; 1; 18
SECONDARY
Change From Baseline in Body Weight
-0.19; -0.34; -1.11; -1.49; -1.38 0.969
SECONDARY
Antibody Production and Effects to LY2189265
0; 0; 1; 0; 0; 0
SECONDARY
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
2294; 6650; 11671; 16649; 31538

Eligibility Criteria

Inclusion Criteria

  • Diabetes mellitus, type 2
  • Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
  • Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
  • Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
  • Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
  • Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m^2, inclusive.
  • Stable weight for 3 months prior to screening

Exclusion Criteria

  • Diabetes mellitus, type 1
  • Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
  • Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
  • Use of medications (prescription or over-the counter) to promote weight loss
  • Chronic (>2 weeks) use of systemic glucocorticoid therapy
  • Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
  • Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release [SR])
  • Cardiovascular event within 6 months prior to screening
  • Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
  • Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
  • Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal
  • Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
  • Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
  • Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance <60 milliliter (mL)/minute which are determined by central labs at the time of screening
  • Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
  • Significant active, uncontrolled endocrine or autoimmune abnormality
  • History of a transplanted organ (corneal transplants are allowed)
  • Active or untreated 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 any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
  • Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
  • Sponsor employees
  • Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  • Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
  • Have previously completed or withdrawn from this study after providing informed consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00791479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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