Mini-Dose Glucagon for Adults With Type 1 Diabetes
Information source: T1D Exchange Clinic Network Coordinating Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: G-Pen Mini™ (glucagon injection) (Drug); Diachieve Glucose Tabs (Other)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: T1D Exchange Clinic Network Coordinating Center Official(s) and/or principal investigator(s): Morey W Haymond, MD, Study Chair, Affiliation: Baylor College of Medicine Stephanie N DuBose, MPH, Principal Investigator, Affiliation: Jaeb Center for Health Research
Overall contact: Christina Carpenter, BS, Phone: 813-975-8690, Email: CCarpenter@jaeb.org
Summary
The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon)
is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes.
Clinical Details
Official title: Mini-Dose Glucagon for Adults With Type 1 Diabetes: A Study to Assess the Efficacy and Safety of Mini-dose Glucagon for Treatment of Non-severe Hypoglycemia in Adults With Type 1 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of events ≥50 mg/dl 15 minutes AND ≥ 70 mg/dl 30 minutes after the start of each non-severe hypoglycemic event (with starting blood glucose 50-69 mg/dl)
Secondary outcome: Proportion of events ≥50 mg/dl 15 minutes AND ≥ 70 mg/dl 30 minutes after the start of each non-severe hypoglycemic event (with starting blood glucose 40-49 mg/dl)Overall continuous glucose monitor (CGM) metric: Mean glucose Overall continuous glucose monitor (CGM) metric: Time in range of 70 to 180 mg/dl Overall continuous glucose monitor (CGM) metric: Glucose variability (coefficient of variation) CGM Metric: Maximum glucose level CGM Metric: Minimum glucose level CGM Metric:Mean Glucose level CGM Metric: Time in range of 70 to 180 mg/dl CGM Metric:Time to increase of glucose level to 100 mg/dl or by 30 mg/dl CGM Metric: Frequency of CGM glucose levels below 70 after treatment of initial event Symptoms associated with non-severe hypoglycemic events
Detailed description:
There are three phases included in this study: (1) Pre-crossover Trial Pilot Phase, (2)
Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Phase.
1. Pre-crossover Trial Pilot Phase:
Prior to commencing the crossover trial, study enrollment will begin with a pilot phase
for up to 6 participants to assess logistical and safety issues. Participants will
have a screening visit followed by 2 weeks of home use of mini-dose glucagon to treat
non-severe hypoglycemia or to prevent the development of hypoglycemia. At the
completion of the 2 weeks, a clinic visit will occur.
Following completion of this pilot phase, study results will be assessed to determine
whether any changes in the crossover trial protocol are warranted.
Participants in the pilot phase can participate in the crossover trial if eligibility
criteria are met.
2. Randomized Clinical Trial (RCT) Crossover Trial Phase Crossover Trial Phase:
The Crossover Trial Phase will start with a run-in phase of up to 48 participants for 2
weeks followed by two (3-week) periods of the crossover trial.
The Crossover Trial Phase will include 24 participants who complete these study
periods. Participants who do not complete both periods or who do not have at least one
event during both periods may be replaced.
During the Crossover Trial Phase participants will be randomized into two groups: (1)
Group A will use mini-dose glucagon in period 1 and oral glucose tablets in period 2
and (2) Group B will use oral glucose tablets in period 1 and mini-dose glucagon in
period 2. Each group with follow the applicable treatment arm according to their
randomized group.
3. Post-Crossover Trial Phase:
The Post-Crossover Trial phase will commence upon completion of the second 3-week period of
the Crossover Trial Phase. Participants will have a 3 week phase during which time they will
decide how and when to use mini-dose glucagon or glucose tablets to treat non-severe
hypoglycemia or to prevent hypoglycemia.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin
2. Age: 18. 0 to < 65. 0 years
3. Duration of T1D: ≥2. 0 years
4. Body mass index 20. 0 to <35. 0 kg/m2 and weight 110 to <250 lbs
5. HbA1c <8. 5% (point of care or local lab, within past month)
6. Using CSII therapy (i. e., insulin pump) for at least 3 months, with no plans to
discontinue use during the study (and no use of active low glucose suspend feature
within the last 4 weeks)
7. Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to
discontinue continuous glucose monitor use during the study
8. Continuous glucose monitor glucose level <70 mg/dl during daytime hours (e. g., 8am -
10pm) on at least 7 of the past 28 days (a modification can be made for participants
with non-traditional waking hours) evaluated from downloaded CGM data
9. Females must meet one of the following criteria:
- Of childbearing potential and not currently pregnant (negative pregnancy test)
or lactating, and agrees to use an accepted contraceptive regimen as described
in the study procedure manual throughout the entire duration of the study (from
screening visit until study completion); or
- Of non-childbearing potential, defined as a female who has had a hysterectomy or
tubal ligation, is clinically considered infertile or is in a menopausal state
(at least 1 year without menses)
10. In good general health with no conditions that could influence the outcome of the
trial, and in the judgment of the investigator is a good candidate for the study
based on review of available medical history, physical examination and clinical
laboratory evaluations
11. Willing to adhere to the protocol requirements for the duration of the study
12. Participant has a smart phone available and is able to use it daily
13. Must be enrolled in the T1D Exchange clinic registry or willing to join the clinic
registry
Exclusion Criteria:
1. More than 1 severe hypoglycemic episode in the past 12 months (as defined by an
episode that required third party assistance for treatment)
2. More than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an
episode diagnosed as diabetic ketoacidosis that required treatment in an emergency
department or hospitalization)
3. Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical
condition which, in the judgment of the investigator, could potentiate or predispose
to undesired effects or could interfere with the absorption, distribution,
metabolism, or excretion of glucagon or ability to respond appropriately to mild to
moderate hypoglycemia.
4. Known presence of hereditary problems of glycogen storage disease, galactose and/or
lactose intolerance
5. Males with alcohol use in excess of 3 or more drinks per day, on average and females
with alcohol use in excess of 2 or more drinks per day, on average
6. Use of non-insulin anti-diabetic medications
7. Use of daily systemic beta-blocker
8. Use of beta-adrenergic agonists, theophylline (or other methylxanthines)
9. Use of 1st generation anticholinergic drugs (such as Brompheniramine,
Chlorpheniramine, Dimenhydrinate, Diphenhydramine, and Doxylamine)
10. Use of systemic corticosteroids
11. History of hypersensitivity to glucagon or any related product or excipient or severe
hypersensitivity reactions (such as angioedema) to any drugs
12. History of epilepsy or seizure disorder
13. Uncontrolled hypertension, >160 mmHg systolic or >100 mmHg diastolic
14. Currently a high endurance exerciser or plans to perform high endurance exercise
during study (from screening visit until study completion)
- High endurance exerciser defined as a person who regularly competes in running,
cycling, rowing, swimming or any other endurance-based activity for the purpose
of competition (>2100 MET minutes per week [i. e. 7 METs x 60 minutes x 5 days a
week, where 7 METS is equivalent to jogging])
15. Currently following a very low calorie or other weight-loss diet
16. Participation in other studies involving administration of an investigational drug or
device within 30 days or 5 half-lives, whichever is longer, before screening for the
current study or planning to participate in another such study during participation
in the current study
Locations and Contacts
Christina Carpenter, BS, Phone: 813-975-8690, Email: CCarpenter@jaeb.org
University of Colorado/Barbara Davis Center for Diabetes, Aurora, Colorado 80045, United States; Not yet recruiting Viral Shah, MD, Phone: 303-724-8186, Email: viral.shah@ucdenver.edu
Yale University of Medicine, New Haven, Connecticut 06510, United States; Not yet recruiting Jennifer Sherr, MD, PhD, Phone: 203-785-2483, Email: Jennifer.Sherr@yale.edu
University of South Florida Diabetes Center, Tampa, Florida 33612, United States; Not yet recruiting Henry Rodriguez, MD, Phone: 813-974-1073, Email: hrodrig1@health.usf.edu
Joslin Diabetes Center, Boston, Massachusetts 02215, United States; Not yet recruiting Howard Wolpert, MD, Phone: 617-732-2665, Email: howard.wolpert@joslin.harvard.edu
SUNY Upstate Medical University, Syracuse, New York 13210, United States; Not yet recruiting Ruth Weinstock, MD, PhD, Phone: 315-464-9006, Email: weinstor@upstate.edu
University of Pennsylvania, Philadephia, Pennsylvania 19104, United States; Not yet recruiting Michael Rickels, MD, MS, Phone: 215-746-0025, Email: rickels@mail.med.upenn.edu
Additional Information
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
Related publications: Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes. 2008 Dec;57(12):3169-76. doi: 10.2337/db08-1084. Review. Cryer PE. Hypoglycemia in type 1 diabetes mellitus. Endocrinol Metab Clin North Am. 2010 Sep;39(3):641-54. doi: 10.1016/j.ecl.2010.05.003. Review. Raju B, Arbelaez AM, Breckenridge SM, Cryer PE. Nocturnal hypoglycemia in type 1 diabetes: an assessment of preventive bedtime treatments. J Clin Endocrinol Metab. 2006 Jun;91(6):2087-92. Epub 2006 Feb 21. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8. Haymond MW, Schreiner B. Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes. Diabetes Care. 2001 Apr;24(4):643-5. Hartley M, Thomsett MJ, Cotterill AM. Mini-dose glucagon rescue for mild hypoglycaemia in children with type 1 diabetes: the Brisbane experience. J Paediatr Child Health. 2006 Mar;42(3):108-11. Hasan KS, Kabbani M. Mini-dose glucagon is effective at diabetes camp. J Pediatr. 2004 Jun;144(6):834.
Starting date: July 2015
Last updated: June 1, 2015
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