June 13, 2020
New data from a real-word evidence study found starting both an insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) closely together in time (within ≤90 days and ideally ≤30 days) in adults with uncontrolled type 2 diabetes (A1c ≥ 9%) while on oral antidiabetic drugs led to a significantly higher probability of achieving target blood sugar control (A1c <7%) compared with initiating these two therapies more than three months to one year apart. The data was presented today during the American Diabetes Association (ADA) 80th Scientific Sessions – A Virtual Experience.
“In my practice, individuals with high blood sugar levels, particularly those over 9 percent, are at high risk for developing comorbidities due to the progressive nature of diabetes associated with advanced disease, said Juan Frias, MD, President and Principal Investigator of the National Research Institute in Los Angeles, California, and an investigator of the study. “A benefit of real-world evidence is that it provides insight into the effectiveness of therapies in real-life practice. In this study, the real-world data shows the potential benefits that starting simultaneous insulin and GLP-1 RA therapies early could have on adults with severely uncontrolled type 2 diabetes.”
Within the same population, the study also found starting both an insulin and GLP-1 RA within at least ≤90 days led to more patients achieving blood sugar levels of <7% or <8% and more patients reducing their blood sugar levels by ≥1-2% at six and 12 months compared with starting these two therapies more than three months to one year apart. Patients participating in this study were prescribed either a long-acting or intermediate-acting insulin. Real-world evidence data was compiled from the Optum Humedica database of electronic medical records and claims (1/1/2011 to 6/30/2017), which serves as a large and diverse data set representative of the U.S. population.
“Patients with uncontrolled type 2 diabetes, specifically those with blood sugar levels greater than 1.5-2 percent above goal, represent a clinical challenge, and ADA treatment guidelines suggest initiating combination therapy for these patients,” said Rogelio Braceras, MD, North America Medical Head of General Medicines, Sanofi. “The complementary actions of a GLP-1 RA and an insulin, when initiated simultaneously, may provide an effective approach for adults with uncontrolled type 2 diabetes. Sanofi is dedicated to providing the diabetes community with robust real-world evidence to ensure healthcare professionals and patients can make informed treatment decisions that meet each person’s individual needs.”
Click here to view this data’s poster and hear about the data from one of the study’s authors.
Table: Percentage of patients achieving glycemic control by initiation |
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|
Simultaneous |
Sequential Initiation |
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|
Cohort A |
Cohort B |
Cohort C |
Cohort D |
Cohort E |
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At baseline, N |
1420 |
1259 |
1325 |
1205 |
1130 |
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HbA1c, %, mean ± SD |
10.9 ± 1.5 |
10.7 ± 1.5 |
10.5 ± 1.3 |
10.5 ± 1.4 |
10.6 ± 1.4 |
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HbA1c, %, median (Q1–Q3) |
10.6 (9.7–11.8) |
10.4 (9.6–11.7) |
10.1 (9.4–11.1) |
10.1 (9.5–11.2) |
10.2 (9.5–11.3) |
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|
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At 6 months, N |
1188 |
1091 |
1174 |
1082 |
1006 |
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Patients achieving HbA1c <7 %, % (95% CI) |
24.4 (22.0–26.9) |
17.8 (15.5–20.1) |
8.7 (7.1–10.3) |
9.4 (7.7–11.2) |
11.5 (9.6–13.5) |
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Patients achieving HbA1c <8 %, % (95% CI) |
45.3 (42.5–48.1) |
38.8 (35.9–41.7) |
29.8 (27.2–32.4) |
28.7 (26.0–31.3) |
30.1 (27.3–33.0) |
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Patients achieving ≥1 % reduction in HbA1c, % (95% CI) |
72.2 (69.7–74.8) |
67.8 (65.1–70.6) |
58.4 (55.6–61.3) |
57.8 (54.8–60.7) |
58.6 (55.6–61.7) |
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Patients achieving ≥2 % reduction in HbA1c, % (95% CI) |
53.0 (50.2–55.9) |
47.2 (44.2–50.2) |
33.3 (30.6–36.0) |
35.0 (32.2–37.9) |
36.7 (33.7–39.7) |
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|
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At 12 months, N |
1044 |
942 |
1011 |
902 |
884 |
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Patients achieving HbA1c <7 %, % (95% CI) |
19.3 (17.0–21.7) |
19.0 (16.5–21.5) |
11.4 (9.4–13.3) |
9.9 (7.9–11.8) |
10.7 (8.7–12.8) |
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Patients achieving HbA1c <8 %, % (95% CI) |
40.9 (37.9–43.9) |
40.3 (37.2–43.5) |
32.4 (29.6–35.3) |
31.3 (28.2–34.3) |
30.4 (27.4–33.5) |
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Patients achieving ≥1 % reduction in HbA1c, % (95% CI) |
70.4 (67.6–73.2) |
67.2 (64.2–70.2) |
58.7 (55.6–61.7) |
60.5 (57.3–63.7) |
58.3 (55.0–61.5) |
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Patients achieving ≥2 % reduction in HbA1c, % (95% CI) |
51.1 (48.0–54.1) |
49.2 (46.0–52.3) |
37.2 (34.2–40.2) |
35.9 (32.8–39.1) |
37.6 (34.4–40.7) |
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Optum Humedica EMR database |
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CI, confidence interval; EMR, electronic medical records; N, total number of patients with at least one HbA1c measurement in the period; SD, standard deviation |
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