Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
| Group | Value (Hypoglycemic Events) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 58 |
| Glucose Tabs | 53 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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 (T1D).
Experimental
G-Pen Mini™ (glucagon injection)
Participants are to check blood glucose (BG) with study meter once their continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants will be instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
Active comparator
Glucose Tabs
Participants are to check their blood glucose (BG) with study meter once their continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants will be instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
Outcomes the sponsor listed as primary.
Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
Time frame · 30 minutes
Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level
Time frame · 60 Minutes
Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
CGM Maximum Glucose, Event Level
Time frame · 60 Minutes
Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
CGM Mean Glucose, Event Level
Time frame · 60 Minutes
Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
CGM Time in Range, Event Level
Time frame · 60 Minutes
Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
CGM Time Below 70 mg/dL, Event Level
Time frame · 60 Minutes
Percentage of time \<70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
CGM Minimum Glucose, Event Level
Time frame · 120 Minutes
Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
CGM Maximum Glucose, Event Level
Time frame · 120 Minutes
Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
CGM Mean Glucose, Event Level
Time frame · 120 Minutes
Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
CGM Time in Range, Event Level
Time frame · 120 Minutes
Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
CGM Time Below 70 mg/dL
Time frame · 120 Minutes
Percentage of time \<70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
CGM Mean Glucose
Time frame · 3 weeks
Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period
CGM Time in Range
Time frame · 3 weeks
Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period
CGM Time Below 70
Time frame · 3 weeks
Percentage of time \<70 mg/dL from CGM data computed over entire 3 weeks of treatment period
CGM Coefficient of Variation
Time frame · 3 weeks
Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Hypoglycemic Events) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 58 |
| Glucose Tabs | 53 |
| Group | Value (mg/dL) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 59 |
| Glucose Tabs | 56 |
| Group | Value (mg/dL) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 102 |
| Glucose Tabs | 116 |
| Group | Value (mg/dL) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 79 |
| Glucose Tabs | 87 |
| Group | Value (percentage of time) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 62 |
| Glucose Tabs | 67 |
| Group | Value (percentage of time) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 35 |
| Glucose Tabs | 33 |
| Group | Value (mg/dL) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 57 |
| Glucose Tabs | 56 |
| Group | Value (mg/dL) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) | 122 |
| Glucose Tabs | 139 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| G-Pen Mini™ (Glucagon Injection)Participants treat non-severe hypoglycemic events with glucagon. | 0 / 20 | 0 / 20 | 2 / 20 |
| Glucose TabsParticipants treat non-severe hypoglycemic events with glucose tabs. | 0 / 20 | 0 / 20 | 1 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2001
Haymond et al. 2001Diabetes carecited by 71
PMID 11315823DOI 10.2337/diacare.24.4.643PUB-11315823
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated