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

NCT01087567 | Completed Phase 4 DMC

• 1 other identifier: 16037
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

diabetes; insulin; rescue therapy

Outcome Measures

Primary Outcomes (4)

• The need for rescue therapy

  at 3 months

• The need for rescue therapy

  at 6 months

• The need for rescue therapy

  at 9 months

• The need for rescue therapy

  at 12 months

Secondary Outcomes (1)

• A1c,C-peptide. Time to normoglycemia and rescue therapy. Mean glucose, mean FBG, HOMA-B, HOMA-IR. Hypoglycemic events (minor and major. Tolerability based on side effects.

  3 months, 6 months, 9 months, 12 months

Study Arms (2)

Intensive insulin regimen

EXPERIMENTAL

A weight based, basal bolus will be given for 12 weeks.

Drug: Intensive insulin

Routine Care

ACTIVE COMPARATOR

Routine Care patients receive oral medications based upon the 2009 ADA treatment recommendations: Metformin, Glimepiride, Pioglitazone.

Drug: Routine Care

Interventions

Intensive insulin DRUG

A weight-based basal bolus insulin regimen starting with 0.1 units/kg/day of Glargine and 4 units/meal of Glulisine.

Also known as: Lantus Insulin, Apidra Insulin

Intensive insulin regimen

Routine Care DRUG

Treatment in routine care will be based upon the 2009 ADA treatment recommendations.

Also known as: Metformin, Glimepiride, Pioglitazone

Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead
• Western University of Health Sciences: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (3)

• Ryan EA, Imes S, Wallace C. Short-term intensive insulin therapy in newly diagnosed type 2 diabetes. Diabetes Care. 2004 May;27(5):1028-32. doi: 10.2337/diacare.27.5.1028.

  PMID: 15111515 BACKGROUND

• Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.

  PMID: 18502299 BACKGROUND

• Chen HS, Wu TE, Jap TS, Hsiao LC, Lee SH, Lin HD. Beneficial effects of insulin on glycemic control and beta-cell function in newly diagnosed type 2 diabetes with severe hyperglycemia after short-term intensive insulin therapy. Diabetes Care. 2008 Oct;31(10):1927-32. doi: 10.2337/dc08-0075. Epub 2008 Jun 12.

  PMID: 18556343 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine; insulin glulisine; Metformin; glimepiride; Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jay H Shubrook, D.O.

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (1)