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

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ClinicalTrials.gov Identifier: NCT01087567
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Western University of Health Sciences
Information provided by (Responsible Party):
Jay Shubrook, Ohio University

Tracking Information
First Submitted Date  ICMJE March 15, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date April 21, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
  • The need for rescue therapy [ Time Frame: at 3 months ]
  • The need for rescue therapy [ Time Frame: at 6 months ]
  • The need for rescue therapy [ Time Frame: at 9 months ]
  • The need for rescue therapy [ Time Frame: at 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
The need for rescue therapy [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
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. [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INSPIRE Diabetes Study: Basal Bolus Insulin as Primary Treatment of Type 2 Diabetes
Official Title  ICMJE A Pilot Study of Intensive Insulin Regimen as a Primary Treatment of New Onset of Type 2 DM
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.

Detailed Description

Insulin, when used as an initial treatment of T2DM, has a great potential to produce glucose control faster than any other treatment regimen. However, it is typically used as the treatment of last resort in T2DM. In this study, the investigators offer a novel approach to use insulin as the initial therapy in new-onset T2DM with the aim of determining its efficacy toward producing lasting glucose control.

Hypothesis: Treating newly diagnosed T2DM patients with insulin therapy versus standard of care for a short period of time will lead to improvement in glycemic control that is durable beyond the length of time taking the insulin and it may improve beta cell function.

Primary endpoints: Time to need rescue therapy, Need for rescue therapy at all time points. A1C change at 3, 6, 9 and 12 months.

Secondary endpoints: Mean glucose and mean fasting glucose at 3, 6, 12 months. C-peptide, HOMA-B, HOMA-IR, A1C the same time points, OGTT at week 12 and 56. Total number of hypoglycemic events (minor and major) and tolerability based on side effects.

Treatment arm: Weight based protocol of insulin Glargine and Glulisine. Control arm: oral medications per ADA 2009 recommended treatment algorithm. Rescue group available for both arms after initial 12 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Intensive insulin
    A weight-based basal bolus insulin regimen starting with 0.1 units/kg/day of Glargine and 4 units/meal of Glulisine.
    Other Names:
    • Lantus Insulin
    • Apidra Insulin
  • Drug: Routine Care
    Treatment in routine care will be based upon the 2009 ADA treatment recommendations.
    Other Names:
    • Metformin
    • Glimepiride
    • Pioglitazone
Study Arms  ICMJE
  • Experimental: Intensive insulin regimen
    A weight based, basal bolus will be given for 12 weeks.
    Intervention: Drug: Intensive insulin
  • Active Comparator: Routine Care
    Routine Care patients receive oral medications based upon the 2009 ADA treatment recommendations: Metformin, Glimepiride, Pioglitazone.
    Intervention: Drug: Routine Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2014)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2010)
60
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087567
Other Study ID Numbers  ICMJE 16037
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jay Shubrook, Ohio University
Original Responsible Party Jay Shubrook, D.O., Associate Professor, Ohio University
Current Study Sponsor  ICMJE Ohio University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Western University of Health Sciences
Investigators  ICMJE
Principal Investigator: Jay H Shubrook, D.O. Ohio University
PRS Account Ohio University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP