Diabetes Obes Metab: Based on the baseline glycosylated hemoglobin (HbA1c) subgroup to expand the dose range of the blood glucose efficacy of dulaglutide

Background: In type 2 diabetes, maintaining stable blood glucose levels over time usually requires increasing the amount of current medications or starting a new treatment plan (increasing or switching) to strengthen the treatment
.
Many patients recommend the use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) to reduce glycosylated hemoglobin (HbA1c) and bring cardiovascular benefits without increasing the risk of hypoglycemia or weight gain

.

Maintaining stable blood glucose levels usually requires increasing the amount of current medications or starting a new treatment plan (increase or switch) to strengthen the treatment of glucagon-like peptide-1 receptor agonists (GLP-1RAs) to reduce glycosylated hemoglobin (HbA1c) ) And bring cardiovascular benefits without increasing the risk of hypoglycemia or weight gain

Method: This is a randomized, phase 3, double-blind, multi-center, parallel controlled trial
.
The patient started by injecting 0.

75 mg of dulaglycotide once a week for 4 weeks, and then gradually increased the dose every 4 weeks to a random dose of 1.

Primary efficacy indicators (changes from baseline in HbA1c) and secondary efficacy indicators (proportion of patients with HbA1c <53 mmol/mol [7.
0%], changes in fasting blood glucose levels from baseline, and changes in body weight from baseline)
.
For the current exploratory analysis, in the following subgroup of reduced blood glucose control defined by baseline HbA1c, the change from baseline in HbA1c and the proportion of patients who achieved HbA1c <53 mmol/mol at 36 and 52 weeks were evaluated: <8% ; 8% to <9%; 9% to <10%; and ≥10%

.

Safety assessment: Including the incidence of common gastrointestinal (GI) reactions (nausea, vomiting, and diarrhea) and hypoglycemic episodes (clinically significant hypoglycemia [Grade 2, that is, blood glucose levels <3.
0 mmol/L or 54 mg/dl ]; Severe hypoglycemia (Grade 3, that is, changes in mental and/or physical function, requiring help from others to recover, lasting up to 52 weeks)
.

Safety assessment:

Results: At 36 weeks, the HbA1c of all baseline HbA1c subgroups decreased on average (HbA1c variation range: 1.
5 mg: -1.
0%~-2.
2%; 3.
0 mg: -1.
2%~-2.
5%; 4.
5 mg: -1.
2%~- 3.
2%)
.
Regardless of the baseline glycosylated hemoglobin (HbA1c), patients randomly taking 3.

0mg HbA1c or 4.

result:

Figure Glycated hemoglobin (HbA1c) changes from baseline and the proportion of patients reaching the HbA1c target at 36 and 52 weeks
.

Figure Glycated hemoglobin (HbA1c) changes from baseline and the proportion of patients reaching the HbA1c target at 36 and 52 weeks
.

N=Patients whose baseline value is not missing and at least one response variable is not missing after the baseline value

.

N=Patients whose baseline value is not missing and at least one response variable is not missing after the baseline value

The incidence of gastrointestinal and hypoglycemic events in the epiduraglycotide treatment group and the baseline glycosylated hemoglobin subgroup within 52 weeks

The incidence of gastrointestinal and hypoglycemic events in the epiduraglycotide treatment group and the baseline glycosylated hemoglobin subgroup within 52 weeks

Conclusion: In the baseline glycosylated hemoglobin (HbA1c) subgroup, as the dose of dulaglutide increased from 1.
5 mg to 3.
0 mg or 4.
5 mg, blood glucose control was improved (<8%; 8.
0%-<9.
0%; 9.
0%) -<10%; ≥10%)
.

In the baseline glycosylated hemoglobin (HbA1c) subgroup, as the dose of dulaglutide increased from 1.
5 mg to 3.
0 mg or 4.
5 mg, blood glucose control improved (<8%; 8.
0%-<9.
0%; 9.
0%-< 10%; ≥ 10%)
.

Original source:

Frias JP, Bonora E, Cox DA, et al.

Glycemic Efficacy of an Expanded Dose Range of Dulaglutide by Baseline HbA1c Subgroups: Post hoc Analysis of AWARD-11.

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