Suprefort Improves Glycemic Control in Type 2 Diabetes: A Pilot Study
Dedov I.I., Shestakova M.V., Mayorov A.Y.
Endocrinology Research Center
Diabetes Research and Clinical Practice 118(1): 112-119
Abstract
Type 2 diabetes (T2D) is characterized by progressive beta-cell dysfunction and insulin resistance. This pilot study evaluated Suprefort (pancreatic peptide complex) in T2D patients inadequately controlled on metformin alone. Ninety-six patients (HbA1c 7.5-9.5%) received either metformin plus Suprefort (20mg orally twice daily for 90 days, n=48) or metformin alone (n=48). Primary endpoint was change in HbA1c at 90 days. The Suprefort group showed significantly greater HbA1c reduction (from 8.3±0.7% to 7.1±0.8% vs. control reduction to 7.9±0.9%, p<0.01). Fasting plasma glucose decreased by 1.8±0.6 mmol/L vs. 0.7±0.5 mmol/L (p<0.001). HOMA-IR (insulin resistance index) improved by 32% in Suprefort group vs. 12% in controls. C-peptide levels (marker of beta-cell function) increased, suggesting preserved insulin secretion. Homeostatic model assessment of beta-cell function (HOMA-B) improved 28%. Lipid profiles showed reduced triglycerides and improved HDL cholesterol. Weight remained stable in both groups.
Study Population
Type 2 diabetes patients (age 45-68 years), HbA1c 7.5-9.5% on metformin monotherapy, BMI 27-35 kg/m², disease duration 3-8 years
Background
Type 2 diabetes progressively worsens as pancreatic beta-cells fail. Most medications eventually lose effectiveness. Preserving beta-cell function is a key therapeutic goal.
Study Design
Diabetic patients inadequately controlled on metformin alone received Suprefort as add-on therapy.
Results
Glycemic Control
HbA1c (the gold standard diabetes marker reflecting 3-month average glucose) improved dramatically:
- Suprefort group: 8.3% → 7.1% (near target!)
- Control group: 8.3% → 7.9% (minimal change)
This 3x greater reduction is clinically meaningful.
Insulin Sensitivity
HOMA-IR (insulin resistance index) improved by 32% with Suprefort vs. only 12% with metformin alone, indicating the peptide enhances insulin effectiveness.
Beta-Cell Preservation
The most exciting finding: C-peptide levels increased by 18%, suggesting Suprefort actually preserves or enhances pancreatic insulin production.
HOMA-B (beta-cell function index) improved 28% - this is rare with diabetes medications.
Metabolic Benefits
Beyond glucose:
- Triglycerides decreased 21%
- HDL ("good") cholesterol improved
- No weight gain (common with many diabetes drugs)
Significance
Suprefort appears to address the root problem in T2D: beta-cell dysfunction. This offers hope for disease modification rather than just symptom management.
Future Directions
Larger randomized trials are needed to confirm these promising pilot results and explore long-term beta-cell preservation.
Statistical Results
HbA1c reduction: Suprefort to 7.1±0.8% vs. control to 7.9±0.9% (1.2% vs. 0.4% reduction, p<0.01). Fasting glucose: -1.8±0.6 vs. -0.7±0.5 mmol/L (p<0.001). HOMA-IR improvement: -32% vs. -12% (p<0.01). HOMA-B increase: +28% vs. +8% (p<0.05). C-peptide increase: +18% vs. +4% (p<0.05). Triglycerides: -21% vs. -8% (p<0.05).
Study Limitations
- •Pilot study - small sample size
- •Non-randomized design
- •Relatively short duration (90 days)
- •Limited to metformin monotherapy patients
- •Mechanism of beta-cell preservation unclear
- •No diabetes complications assessed
Adverse Events
- •Mild nausea (4.2%)
- •No hypoglycemic events
- •No serious adverse events
- •Weight-neutral
Key Findings
- ✓Significant HbA1c reduction
- ✓Improved insulin sensitivity
- ✓Preservation of beta-cell function
- ✓Better lipid profiles
- ✓Weight-neutral therapy
Mechanism of Action
Enhancement of pancreatic beta-cell protein synthesis, improvement of insulin secretion, reduction of beta-cell apoptosis, and anti-inflammatory effects on pancreatic tissue.