NCT01480843

Brief Summary

The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 8, 2017

Completed
Last Updated

November 8, 2017

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

November 9, 2011

Results QC Date

April 25, 2017

Last Update Submit

October 9, 2017

Conditions

Diabetes

Keywords

simplificationglargineelderly

Outcome Measures

Primary Outcomes (2)

  • Change in Duration of Hypoglycemia Episodes

    duration of hypoglycemia measured by continuous glucose monitoring

    baseline, 5 months, 8 months

  • Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months

    frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data

    baseline, 5 months, 8 months

Study Arms (1)

Glargine

EXPERIMENTAL

We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.

Drug: Glargine

Interventions

GlargineDRUG

Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults

Also known as: Lantus
Glargine

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 70 years or older
  • Diagnosis of diabetes mellitus Type II
  • At least 2 (short-acting or mixed) insulin injections per day
  • At least 1 episode of hypoglycemia (glucose value \<70) on screening CGM

You may not qualify if:

  • Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
  • Active liver disease (history of cirrhosis or LFT \> 3 times normal)
  • On dialysis or with severe renal dysfunction (creatinine clearance \<20 ml/min)
  • Malignancy that limits life span to less than 18 months
  • Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (24)

  • Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050. Diabetes Care. 2006 Sep;29(9):2114-6. doi: 10.2337/dc06-1136. No abstract available.

    PMID: 16936162BACKGROUND

  • Economic consequences of diabetes mellitus in the U.S. in 1997. American Diabetes Association. Diabetes Care. 1998 Feb;21(2):296-309. doi: 10.2337/diacare.21.2.296.

    PMID: 9539999BACKGROUND

  • Bertoni AG, Kirk JK, Goff DC Jr, Wagenknecht LE. Excess mortality related to diabetes mellitus in elderly Medicare beneficiaries. Ann Epidemiol. 2004 May;14(5):362-7. doi: 10.1016/j.annepidem.2003.09.004.

    PMID: 15177276BACKGROUND

  • Blaum CS, Ofstedal MB, Langa KM, Wray LA. Functional status and health outcomes in older americans with diabetes mellitus. J Am Geriatr Soc. 2003 Jun;51(6):745-53. doi: 10.1046/j.1365-2389.2003.51256.x.

    PMID: 12757559BACKGROUND

  • Bonsignore P DL, Suhl E, Sternthal A, Giusti J, Munshi MN. Unrecognized Errors in Insulin Injection Techniques Are Frequent in Older Adults Even with Longer Duration of Insulin Use. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 913-P.

    BACKGROUND

  • Medha N. Munshi EB, Ramachandiran Cooppan. Diabetes in the Older Adult. In: Richard S. Beaser MatSoJDC, ed. Joslin's Diabetes Deskbook : A guide for primary care providers. 2nd ed. Boston: Joslin Diabetes Center; 2007:623-38.

    BACKGROUND

  • Shorr RI, Ray WA, Daugherty JR, Griffin MR. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med. 1997 Aug 11-25;157(15):1681-6.

    PMID: 9250229BACKGROUND

  • McAulay V FB. Hypoglycemia in diabetes in old age. In: Sinclair A, Finucane P, ed. 2nd ed. Chichester, UK: John wiley and sons; 2001:133-52.

    BACKGROUND

  • Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9. doi: 10.2337/diacare.26.5.1485.

    PMID: 12716809BACKGROUND

  • Frier BM. Hypoglycaemic valleys: an under-recognised problem in type 2 diabetes? Int J Clin Pract Suppl. 2002 Jul;(129):12-9.

    PMID: 12166599BACKGROUND

  • Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005 Dec;28(12):2948-61. doi: 10.2337/diacare.28.12.2948. No abstract available.

    PMID: 16306561BACKGROUND

  • Ayres D SE, Capelson R, Weinger K, Munshi M. Identifying Barriers to Diabetes Education and Self-Care in Older Adults. In: American diabetes Association 65th scientific sessions 2005; San Diego CA; 2005. p. 941-P

    BACKGROUND

  • Munshi M, Grande L, Hayes M, Ayres D, Suhl E, Capelson R, Lin S, Milberg W, Weinger K. Cognitive dysfunction is associated with poor diabetes control in older adults. Diabetes Care. 2006 Aug;29(8):1794-9. doi: 10.2337/dc06-0506.

    PMID: 16873782BACKGROUND

  • Munshi MN DL, Iwata I, Suhl E, Giusti J, Bonsignore P, Sternthal A The Risk of Hypoglycemia Is a Treatment-Limiting Factor in Older Adults Even with Poor Glycemic Control. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 2123-PO.

    BACKGROUND

  • Munshi MN, Hayes M, Sternthal A, Ayres D. Use of serum c-peptide level to simplify diabetes treatment regimens in older adults. Am J Med. 2009 Apr;122(4):395-7. doi: 10.1016/j.amjmed.2008.12.008.

    PMID: 19332236BACKGROUND

  • Kovatchev BP, Clarke WL, Breton M, Brayman K, McCall A. Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther. 2005 Dec;7(6):849-62. doi: 10.1089/dia.2005.7.849.

    PMID: 16386091BACKGROUND

  • Hendriksen C, Faber OK, Drejer J, Binder C. Prevalence of residual B-cell function in insulin-treated diabetics evaluated by the plasma C-etide response to intravenous glucagon. Diabetologia. 1977 Dec;13(6):615-9. doi: 10.1007/BF01236316.

    PMID: 338408BACKGROUND

  • Faber OK, Binder C. C-peptide response to glucagon. A test for the residual beta-cell function in diabetes mellitus. Diabetes. 1977 Jul;26(7):605-10. doi: 10.2337/diab.26.7.605.

    PMID: 326604BACKGROUND

  • Montorio I, Izal M. The Geriatric Depression Scale: a review of its development and utility. Int Psychogeriatr. 1996 Spring;8(1):103-12. doi: 10.1017/s1041610296002505.

    PMID: 8805091BACKGROUND

  • Arbuthnott K, Frank J. Trail making test, part B as a measure of executive control: validation using a set-switching paradigm. J Clin Exp Neuropsychol. 2000 Aug;22(4):518-28. doi: 10.1076/1380-3395(200008)22:4;1-0;FT518.

    PMID: 10923061BACKGROUND

  • Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003 Jan;20(1):69-72. doi: 10.1046/j.1464-5491.2003.00832.x.

    PMID: 12519323BACKGROUND

  • Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.

    PMID: 7555499BACKGROUND

  • Jacobson AM, de Groot M, Samson JA. The evaluation of two measures of quality of life in patients with type I and type II diabetes. Diabetes Care. 1994 Apr;17(4):267-74. doi: 10.2337/diacare.17.4.267.

    PMID: 8026281BACKGROUND

  • Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.

    PMID: 15920050BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Medha Munshi, MD
Organization
Joslin Diabetes Center
medha.munshi@joslin.harvard.edu
617-309-4683

Study Officials

  • Medha N Munshi, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 29, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 8, 2017

Results First Posted

November 8, 2017

Record last verified: 2017-10

Locations

US(1)