Phase 3
Completed N=360
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01406717 ↗Enrolled (actual)
360
Serious AEs
1.9%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline to End of Study in Hemoglobin A1c (HbA1c) — -0.227; -0.227 percentage of hemoglobin A1c (HbA1c)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Study in Hemoglobin A1c (HbA1c) |
-0.227; -0.227 | — |
| PRIMARY Change From Baseline to End of Study in Fasting Plasma Glucose (FPG) |
0.48; -5.42 | — |
| PRIMARY Count and Percentage of Subjects Positive for Anti-exenatide Antibodies |
59; 2 | <0.0001 sig |
| PRIMARY Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs) |
3; 3 | — |
| SECONDARY Change From Baseline in 2hour Postprandial Glucose (2-h PPG) |
-21.20; -16.83 | 0.6318 |
| SECONDARY Change From Baseline in Triglycerides |
1.27; 8.39 | 0.4887 |
| SECONDARY Change From Baseline in Low Density Lipoproteins |
-3.18; 0.15 | 0.3813 |
| SECONDARY Change From Baseline in High Density Lipoproteins |
0.64; 0.62 | 0.9900 |
| SECONDARY Change in Body Weight |
-1.708; -0.792 | 0.0017 sig |
| SECONDARY Subjects Achieving Hemoglobin A1c (HbA1c) < 7% |
26; 20 | 0.6098 |
| SECONDARY Change From Baseline in Very Low Density Lipoproteins |
0.88; 1.55 | 0.7324 |
| SECONDARY Change From Baseline in Total Cholesterol |
-4.89; -0.11 | 0.2984 |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 20 years of age and older.
- Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
- Weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit.
- Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test.
- Willing to participate and give written informed consent.
Exclusion Criteria
- Previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (GLP-1) analogue.
- Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening.
- Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry.
- Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.
Data sourced from ClinicalTrials.gov (NCT01406717). 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.