INSPIRE Diabetes Study: Basal Bolus Insulin as Primary Treatment of Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

T2DM has become an American Epidemic. Currently 8% of the US population has diabetes and rates may be as high as 33% by the year 2050 (1). Although there are many treatment options for people with T2DM, none have been proven in humans to prevent the defects in insulin secretion (2) and insulin action (3) and beta cell dysfunction (4) that result with very high glucose levels and typically worsen as the disease progresses. Any treatment that could delay the progression of pancreatic beta cell failure (as measured by the need for rescue therapy with oral agents) would be a significant advancement in diabetes treatment.

Insulin therapy is appropriate at any point in T2DM disease progression, but it is commonly only used as a rescue therapy after failure of oral therapies. A number of outpatient insulin titration protocols have been shown to be safe and effective and speed patient's ability to gain glucose control (5-8). Recent studies have shown that initiation of insulin at onset of T2DM is beneficial at achieving early and long-term glucose control (6-9). However these protocols have used intravenous human insulin in the in-patient setting, continuous subcutaneous insulin by insulin pump or older human insulins in the out-patient setting. Many of these protocols are unlikely to be utilized in routine patient care. To date, no "insulin first" studies have been published with analog insulins in an outpatient basal-bolus regimen with patient driven titration.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio University
• Collaborator: Western University of Health Sciences
• Treatments: Glimepiride; Insulin; Insulin, Globin Zinc; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Newly diagnosed T2DM (≤ 6 months since diagnosis)

• Drug naïve (less than 2 weeks of insulin and OHAs)

• A1C ≥ 8%

• Age ≥ 18 years

• Normal to high baseline C-peptide (≥ 0.5 ug/dL)

• FBG > 180 mg/dL, A1C > 8%.

Exclusion Criteria:

• Pregnancy

• Clinically evident heart failure

• Nephrotic syndrome

• Allergy to insulin or any of the oral medications in the study

• Presence of anti-GAD antibodies

• Islet cell antibodies

• Anti-insulin antibodies

• Any physical disabilities that would preclude self-administration of injectable insulin.

• Evidence of hypoglycemia during screening phase.

• History of lactic acidosis, allergy to metformin or history of chronic renal disease or a serum creatinine > 1.5 in men or > 1.4 in women