Phase 2
Completed N=167
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
| Outcome | Result | p-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
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.