Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
| Group | Value (years) |
|---|---|
| Glargine Insulin U-100 | 1.3 |
| Glimepiride | 1.3 |
| Liraglutide | 1.5 |
| Sitagliptin | 0.8 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name GRADE
United 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 GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.
Active comparator
Sulfonylurea (glimepiride)
Sulfonylurea
Active comparator
DPP-4 inhibitor
DPP-4 inhibitor (sitagliptin)
Active comparator
GLP-1 receptor agonist
GLP-1 receptor agonist (liraglutide)
Active comparator
Insulin (glargine)
Insulin (glargine), Lantus
Outcomes the sponsor listed as primary.
Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
Time frame · Quarterly for 4 to 7 years
The primary metabolic outcome is the time to primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline.
HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication
Time frame · Quarterly, 4-7 years
Number of participants who reached primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline.
Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.
Time frame · Quarterly, 4-6 years
The secondary metabolic outcome is time to HbA1c\>7.5% (58 mmol/mol), confirmed, after addition of randomly assigned glucose-lowering medication at baseline.
HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication.
Time frame · Quarterly for 4 to 7 years
Number of participants who reached primary failure defined as an HbA1c\>7.5% (58 mmol/mol), confirmed, after addition of randomly assigned glucose-lowering medication at baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (years) |
|---|---|
| Glargine Insulin U-100 | 1.3 |
| Glimepiride | 1.3 |
| Liraglutide | 1.5 |
| Sitagliptin | 0.8 |
| Group | Value (Participants) |
|---|---|
| Glargine Insulin U-100 | 852 |
| Glimepiride | 908 |
| Liraglutide | 860 |
| Sitagliptin | 981 |
| Group | Value (years) |
|---|---|
| Glargine Insulin U-100 | 2.1 |
| Glimepiride | 2.0 |
| Liraglutide | 2.2 |
| Sitagliptin | 1.7 |
| Group | Value (Participants) |
|---|---|
| Glargine Insulin U-100 | 498 |
| Glimepiride | 633 |
| Liraglutide | 583 |
| Sitagliptin | 697 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Glargine Insulin U-100Glargine Insulin U-100 was administered daily at an initial dose of up to 20 U and adjusted according to glucose levels monitored by the participant and to avoid hypoglycemia. | 42 / 1263 | 259 / 1263 | 0 / 1263 |
| GlimepirideSulfonylurea glimepiride was increased from 1 to 2 mg to a maximum of 8 mg per day, administered in divided doses and adjusted according to glucose levels monitored by the participant and to avoid hypoglycemia. | 43 / 1254 | 315 / 1254 | 0 / 1254 |
| LiraglutideGLP-1 analog liraglutide was initiated at a dose of 0.6 mg, with escalation to a maximum dose of 1.8 mg daily, depending on gastrointestinal side effects. | 27 / 1262 | 204 / 1262 | 0 / 1262 |
| SitagliptinDPP-4 inhibitor sitagliptin was initiated at a dose of 100 mg, with the dose adjusted according to kidney function. | 41 / 1268 | 272 / 1268 | 0 / 1268 |
| Study Run-In (Metformin Only)During a run-in period of 6 to 14 weeks before randomization, the metformin dose was increased to a minimum of 1000 mg per day, with a target maximal dose (one that could be taken without unacceptable side effects) of 2000 mg per day. | 0 / 7850 | 1 / 7850 | 0 / 7850 |
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.
17 studies on this page
Indexing hint: Meta-analysis (pooled) · 2025
Natale et al. 2025The Cochrane database of systematic reviewscited by 8
PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952
Indexing hint: Randomized controlled trial · 2025
Utzschneider et al. 2025Diabetes carecited by 2
PMID 39998948PMC11932811DOI 10.2337/dc24-2419PUB-39998948
Indexing hint: Randomized controlled trial · 2025
Wexler et al. 2025Diabetes carecited by 7
PMID 40267365PMC12094209DOI 10.2337/dc24-2825PUB-40267365
Indexing hint: Randomized controlled trial · 2025
Luchsinger et al. 2025JAMA internal medicinecited by 6
PMID 40388190PMC12090067DOI 10.1001/jamainternmed.2025.1189PUB-40388190
Indexing hint: Randomized controlled trial · 2025
Hsia et al. 2025Diabetes care
PMID 40424051PMC12178615DOI 10.2337/dc24-2839PUB-40424051
Indexing hint: Randomized controlled trial · 2025
Pop-Busui et al. 2025Diabetes care
PMID 40986645PMC12583396DOI 10.2337/dc25-1087PUB-40986645
Indexing hint: Randomized controlled trial · 2024
Hollander et al. 2024Diabetes carecited by 5
PMID 37756542PMC10973913DOI 10.2337/dc23-0516PUB-37756542
Indexing hint: Randomized controlled trial · 2024
Utzschneider et al. 2024Diabetes carecited by 5
PMID 38190619PMC10973903DOI 10.2337/dc23-1059PUB-38190619
Indexing hint: Randomized controlled trial · 2024
Cherrington et al. 2024Diabetes carecited by 4
PMID 38190625PMC10973906DOI 10.2337/dc23-1648PUB-38190625
Indexing hint: Randomized controlled trial · 2024
Kirkman et al. 2024Diabetes carecited by 5
PMID 38194519PMC10973908DOI 10.2337/dc23-1332PUB-38194519
Indexing hint: Randomized controlled trial · 2024
Rasouli et al. 2024Diabetes carecited by 20
PMID 38211595PMC10973918DOI 10.2337/dc23-1070PUB-38211595
Indexing hint: Randomized controlled trial · 2024
Garvey et al. 2024Diabetes carecited by 12
PMID 38285957PMC10973909DOI 10.2337/dc23-1782PUB-38285957
Indexing hint: Randomized controlled trial · 2024
Green et al. 2024Circulationcited by 22
PMID 38344820PMC10978227DOI 10.1161/circulationaha.123.066604PUB-38344820
Indexing hint: Randomized controlled trial · 2024
Seaquist et al. 2024PloS onecited by 4
PMID 39546502PMC11567630DOI 10.1371/journal.pone.0309907PUB-39546502
Indexing hint: Randomized controlled trial · 2023
Wexler et al. 2023JAMA internal medicinecited by 24
PMID 37213109PMC10203973DOI 10.1001/jamainternmed.2023.1487PUB-37213109
Indexing hint: Randomized controlled trial · 2022
The New England journal of medicinecited by 168
PMID 36129996PMC9829320DOI 10.1056/nejmoa2200433PUB-36129996
Indexing hint: Randomized controlled trial · 2022
The New England journal of medicinecited by 122
PMID 36129997PMC9832916DOI 10.1056/nejmoa2200436PUB-36129997
Indexing hint: Randomized controlled trial · 2020
Sivitz et al. 2020Diabetes carecited by 15
PMID 32139384PMC7171946DOI 10.2337/dc19-1769PUB-32139384
Indexing hint: Randomized controlled trial · 2019
Wexler et al. 2019Diabetes carecited by 38
PMID 31391203PMC6804613DOI 10.2337/dc19-0901PUB-31391203
3 studies on this page
PubMed tag: none · 2024
Hsia et al. 2024Journal of diabetes and its complicationscited by 1
PMID 38354481PMC10923170DOI 10.1016/j.jdiacomp.2024.108692PUB-38354481
PubMed tag: none · 2024
Gonzalez et al. 2024Diabetes carecited by 12
PMID 38416773PMC10973899DOI 10.2337/dc23-2459PUB-38416773
Indexing hint: Randomized controlled trial · 2013
Nathan et al. 2013Diabetes carecited by 211
PMID 23690531PMC3714493DOI 10.2337/dc13-0356PUB-23690531
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