Larry A Distiller1, Hendrik Nortje2, Holger Wellmann3, Aslam Amod4, Landman Lombard5. 1. Centre for Diabetes and Endocrinology, Johannesburg, South Africa. 2. N1 City Medical Chambers, Goodwood, Cape Town, South Africa. 3. Helderberg Clinical Trials Centre, Somerset West, South Africa. 4. Life Chatsmed Garden Hospital and Nelson R Mandela School of Medicine, Durban, South Africa. 5. Kuils River Netcare Hospital, Cape Town, South Africa.
Abstract
OBJECTIVE: To compare the efficacy of 500 U/mL (U-500) regular insulin + metformin with U-500 regular insulin + metformin + exenatide in improving glycemic control in patients with severely insulin-resistant type 2 diabetes mellitus (T2DM). METHODS:Thirty patients with T2DM and severe insulin resistance were screened, and 28 were randomized to regular insulin U-500 + metformin or the GLP-1 analogexenatide, U-500, and metformin. Glycated hemoglobin (HbA1c) levels, body weight, and insulin doses were documented at baseline and at 3 and 6 months. The number and severity hypoglycemic episodes were noted. RESULTS: There were 7 males and 7 females in each group (U-500 + metformin andU-500 + metformin + exenatide). Overall, U-500 insulin + metformin, either alone or with the addition of exenatide, resulted in a significant improvement in HbA1c in both groups, with no significant difference between the 2 groups. There was no meaningful weight change in those utilizing exenatide. Those on U-500 insulin and metformin alone had a tendency toward some weight gain. No severe hypoglycemia occurred during the study period. Symptomatic hypoglycemia was more common in the group on exenatide, but this occurred in only 5 patients, and the clinical significance of this is uncertain. Insulin dosage changes on U-500 regular insulin were variable but tended to be lower in those subjects on exenatide. CONCLUSIONS:U-500regular insulin + metformin is effective for the treatment of T2DM patients with severe insulin resistance. The addition of exenatide may ameliorate potential weight gain but provides no additional improvement in glycemia.
RCT Entities:
OBJECTIVE: To compare the efficacy of 500 U/mL (U-500) regular insulin + metformin with U-500 regular insulin + metformin + exenatide in improving glycemic control in patients with severely insulin-resistant type 2 diabetes mellitus (T2DM). METHODS: Thirty patients with T2DM and severe insulin resistance were screened, and 28 were randomized to regular insulinU-500 + metformin or the GLP-1 analog exenatide, U-500, and metformin. Glycated hemoglobin (HbA1c) levels, body weight, and insulin doses were documented at baseline and at 3 and 6 months. The number and severity hypoglycemic episodes were noted. RESULTS: There were 7 males and 7 females in each group (U-500 + metformin and U-500 + metformin + exenatide). Overall, U-500insulin + metformin, either alone or with the addition of exenatide, resulted in a significant improvement in HbA1c in both groups, with no significant difference between the 2 groups. There was no meaningful weight change in those utilizing exenatide. Those on U-500insulin and metformin alone had a tendency toward some weight gain. No severe hypoglycemia occurred during the study period. Symptomatic hypoglycemia was more common in the group on exenatide, but this occurred in only 5 patients, and the clinical significance of this is uncertain. Insulin dosage changes on U-500 regular insulin were variable but tended to be lower in those subjects on exenatide. CONCLUSIONS:U-500 regular insulin + metformin is effective for the treatment of T2DM patients with severe insulin resistance. The addition of exenatide may ameliorate potential weight gain but provides no additional improvement in glycemia.
Authors: Angelika Sabine Sandholzer-Yilmaz; Eric Sven Kroeber; Wondimu Ayele; T Frese; Eva Johanna Kantelhardt; Susanne Unverzagt Journal: BMJ Open Date: 2022-05-11 Impact factor: 3.006
Authors: Elizabeth L Eby; Bradley H Curtis; Steven C Gelwicks; Robert C Hood; Iskandar Idris; Anne L Peters; Richard M Bergenstal; Jeffrey A Jackson Journal: BMJ Open Diabetes Res Care Date: 2015-04-30